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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter A - General |
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Subpart B - Specific Sector Provisions for Medical Devices |
Appendix B to Subpart B of Part 26 - Scope of Product Coverage
Latest version.
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Appendix B to Subpart B of Part 26 - Scope of Product Coverage
1. Initial Coverage of the Transition Period
Upon entry into force of this subpart as described in § 26.80 (it is understood that the date of entry into force will not occur prior to June 1, 1998, unless the parties decide otherwise), products qualifying for the transitional arrangements under this subpart include:
a. All Class I products requiring premarket evaluations in the United States - see Table 1.
b. Those Class II products listed in Table 2.
2. During the Transition Period
The parties will jointly identify additional product groups, including their related accessories, in line with their respective priorities as follows:
a. Those for which review may be based primarily on written guidance which the parties will use their best efforts to prepare expeditiously; and
b. Those for which review may be based primarily on international standards, in order for the parties to gain the requisite experience.
The corresponding additional product lists will be phased in on an annual basis. The parties may consult with industry and other interested parties in determining which products will be added.
3. Commencement of the Operational Period
a. At the commencement of the operational period, product coverage shall extend to all Class I/II products covered during the transition period.
b. FDA will expand the program to categories of Class II devices as is consistent with the results of the pilot, and with FDA's ability to write guidance documents if the device pilot for the third party review of medical devices is successful. The MRA will cover to the maximum extent feasible all Class II devices listed in Table 3 for which FDA-accredited third party review is available in the United States.
4. Unless explicitly included by joint decision of the parties, this part does not cover any U.S. Class II-tier 3 or any Class III product under either system.
[The lists of medical devices included in these tables are subject to change as a result of the Food and Drug Administration Modernization Act of 1997.]
Table 1 - Class I Products Requiring Premarket Evaluations in the United States, Included in Scope of Product Coverage at Beginning of Transition Period1
21 CFR Section No. Regulation Name Product Code - Device Name Anesthesiology Panel (21 CFR part 868) 868.1910 Esophageal Stethoscope BZW - Stethoscope, Esophageal 868.5620 Breathing Mouthpiece BYP - Mouthpiece, Breathing 868.5640 Medicinal Nonventilatory Nebulizer (Atomizer) CCQ - Nebulizer, Medicinal, Nonventilatory (Atomizer) 868.5675 Rebreathing Device BYW - Device, Rebreathing 868.5700 Nonpowered Oxygen Tent FOG - Hood, Oxygen, Infant BYL - Tent, Oxygen 868.6810 Tracheobronchial Suction Catheter BSY - Catheters, Suction, Tracheobronchial Cardiovascular Panel (None) Dental Panel (21 CFR part 872) 872.3400 Karaya and Sodium Borate With or Without Acacia Denture Adhesive KOM - Adhesive, Denture, Acacia and Karaya With Sodium Borate 872.3700 Dental Mercury (U.S.P.) ELY - Mercury 872.4200 Dental Handpiece and Accessories EBW - Controller, Food, Handpiece and Cord EFB - Handpiece, Air-Powered, Dental EFA - Handpiece, Belt and/or Gear Driven, Dental EGS - Handpiece, Contra- and Right-Angle Attachment, Dental EKX - Handpiece, Direct Drive, AC-Powered EKY - Handpiece, Water-Powered 872.6640 Dental Operative Unit and Accessories EIA - Unit, Operative Dental Ear, Nose, and Throat Panel (21 CFR Part 874) 874.1070 Short Increment Sensitivity Index (SISI) Adapter ETR - Adapter, Short Increment Sensitivity Index (SISI) 874.1500 Gustometer ETM - Gustometer 874.1800 Air or Water Caloric Stimulator KHH - Stimulator, Caloric-Air ETP - Stimulator, Caloric-Water 874.1925 Toynbee Diagnostic Tube ETK - Tube, Toynbee Diagnostic 874.3300 Hearing Aid LRB - Face Plate Hearing-Aid ESD - Hearing-aid, Air-Conduction 874.4100 Epistaxis Balloon EMX - Balloon, Epistaxis 874.5300 ENT Examination and Treatment Unit ETF - Unit, Examining/Treatment, ENT 874.5550 Powered Nasal Irrigator KMA - Irrigator, Powered Nasal 874.5840 Antistammering Device KTH - Device, Anti-Stammering Gastroenterology - Urology Panel (21 CFR Part 876) 876.5160 Urological Clamp for Males FHA - Clamp, Penile 876.5210 Enema Kit FCE - Kit, Enema, (for Cleaning Purpose) 876.5250 Urine Collector and Accessories FAQ - Bag, Urine Collection, Leg, for External Use General Hospital Panel (21 CFR Part 880) 880.5270 Neonatal Eye Pad FOK - Pad, Neonatal Eye 880.5420 Pressure Infusor for an I.V. Bag KZD - Infusor, Pressure, for I.V. Bags 880.5680 Pediatric Position Holder FRP - Holder, Infant Position 880.6250 Patient Examination Glove LZB - Finger Cot FMC - Glove, Patient Examination LYY - Glove, Patient Examination, Latex LZA - Glove, Patient Examination, Poly LZC - Glove, Patient Examination, Speciality LYZ - Glove, Patient Examination, Vinyl 880.6375 Patient Lubricant KMJ - Lubricant, Patient 880.6760 Protective Restraint BRT - Restraint, Patient, Conductive FMQ - Restraint, Protective Neurology Panel (21 CFR Part 882) 882.1030 Ataxiagraph GWW - Ataxiagraph 882.1420 Electroencephalogram (EEG) Signal Spectrum Analyzer GWS - Analyzer, Spectrum, Electroencephalogram Signal 882.4060 Ventricular Cannula HCD - Cannula, Ventricular 882.4545 Shunt System Implantation Instrument GYK - Instrument, Shunt System Implantation 882.4650 Neurosurgical Suture Needle HAS - Needle, Neurosurgical Suture 882.4750 Skull Punch GXJ - Punch, Skull Obstetrics and Gynecology Panel (None) Ophthalmology Panel (21 CFR Part 886) 886.1780 Retinoscope HKM - Retinoscope, Battery-Powered 886.1940 Tonometer Sterilizer HKZ - Sterilizer, Tonometer 886.4070 Powered Corneal Burr HQS - Burr, Corneal, AC-Powered HOG - Burr, Corneal, Battery-Powered HRG - Engine, Trephine, Accessories, AC-Powered HFR - Engine, Trephine, Accessories, Battery-Powered HLD - Engine, Trephine, Accessories, Gas-Powered 886.4370 Keratome HNO - Keratome, AC-Powered HMY - Keratome, Battery-Powered 886.5850 Sunglasses (Nonprescription) HQY - Sunglasses (Nonprescription Including Photosensitive) Orthopedic Panel (21 CFR Part 888) 888.1500 Goniometer KQX - Goniometer, AC-Powered 888.4150 Calipers for Clinical Use KTZ - Caliper Physical Medicine Panel (21 CFR Part 890) 890.3850 Mechanical Wheelchair LBE - Stroller, Adaptive IOR - Wheelchair, Mechanical 890.5180 Manual Patient Rotation Bed INY - Bed, Patient Rotation, Manual 890.5710 Hot or Cold Disposable Pack IMD - Pack, Hot or Cold, Disposable Radiology Panel (21 CFR Part 892) 892.1100 Scintillation (Gamma) Camera IYX - Camera, Scintillation (Gamma) 892.1110 Positron Camera IZC - Camera, Positron 892.1300 Nuclear Rectilinear Scanner IYW - Scanner, Rectilinear, Nuclear 892.1320 Nuclear Uptake Probe IZD - Probe, Uptake, Nuclear 892.1330 Nuclear Whole Body Scanner JAM - Scanner, Whole Body, Nuclear 892.1410 Nuclear Electrocardiograph Synchronizer IVY - Synchronizer, Electrocardiograph, Nuclear 892.1890 Radiographic Film Illuminator IXC - Illuminator, Radiographic-Film JAG - Illuminator, Radiographic-Film, Explosion-Proof 892.1910 Radiographic Grid IXJ - Grid, Radiographic 892.1960 Radiographic Intensifying Screen EAM - Screen, Intensifying, Radiographic 892.1970 Radiographic ECG/Respirator Synchronizer IXO - Synchronizer, ECG/Respirator, Radiographic 892.5650 Manual Radionuclide Applicator System IWG - System, Applicator, Radionuclide, Manual General and Plastic Surgery Panel (21 CFR Part 878) 878.4200 Introduction/Drainage Catheter and Accessories KGZ - Accessories, Catheter GCE - Adaptor, Catheter FGY - Cannula, Injection GBA - Catheter, Balloon Type GBZ - Catheter, Cholangiography GBQ - Catheter, Continuous Irrigation GBY - Catheter, Eustachian, General & Plastic Surgery JCY - Catheter, Infusion GBX - Catheter, Irrigation GBP - Catheter, Multiple Lumen GBO - Catheter, Nephrostomy, General & Plastic Surgery GBN - Catheter, Pediatric, General & Plastic Surgery GBW - Catheter, Peritoneal GBS - Catheter, Ventricular, General & Plastic Surgery GCD - Connector, Catheter GCC - Dilator, Catheter GCB - Needle, Catheter 878.4320 Removable Skin Clip FZQ - Clip, Removable (Skin) 878.4460 Surgeon's Gloves KGO - Surgeon's Gloves 878.4680 Nonpowered, Single Patient, Portable Suction Apparatus GCY - Apparatus, Suction, Single Patient Use, Portable, Nonpowered 878.4760 Removable Skin Staple GDT - Staple, Removable (Skin) 878.4820 AC-Powered, Battery-Powered, and Pneumatically Powered Surgical Instrument Motors and Accessories/Attachments GFG - Bit, Surgical GFA - Blade, Saw, General & Plastic Surgery DWH - Blade, Saw, Surgical, Cardiovascular BRZ - Board, Arm (With Cover) GFE - Brush, Dermabrasion GFF - Bur, Surgical, General & Plastic Surgery KDG - Chisel (Osteotome) GFD - Dermatome GFC - Driver, Surgical, Pin GFB - Head, Surgical, Hammer GEY - Motor, Surgical Instrument, AC-Powered GET - Motor, Surgical Instrument, Pneumatic Powered DWI - Saw, Electrically Powered KFK - Saw, Pneumatically Powered HAB - Saw, Powered, and Accessories 878.4960 Air or AC-Powered Operating Table and Air or AC-Powered Operating Chair & Accessories GBB - Chair, Surgical, AC-Powered FQO - Table, Operating-Room, AC-Powered GDC - Table, Operating-Room, Electrical FWW - Table, Operating-Room, Pneumatic JEA - Table, Surgical with Orthopedic Accessories, AC-Powered 880.5090 Liquid Bandage KMF - Bandage, Liquid Table 2 - Class II Medical Devices Included in Scope of Product Coverage at Beginning of Transition Period (United States to develop guidance documents identifying U.S. requirements and European Community (EC) to identify standards needed to meet EC requirements)1
Panel 21 CFR Section No. Regulation Name Product Code - Device Name RA 892.1000 Magnetic Resonance Diagnostic Device MOS - COIL, Magnetic Resonance, Specialty LNH - System, Nuclear Magnetic Resonance Imaging LNI - System, Nuclear Magnetic Resonance Spectroscopic Diagnostic Ultrasound: RA 892.1540 Nonfetal Ultrasonic Monitor JAF - Monitor, Ultrasonic, Nonfetal RA 892.1550 Ultrasonic Pulsed Doppler Imaging System IYN - System, Imaging, Pulsed Doppler, Ultrasonic RA 892.1560 Ultrasonic Pulsed Echo Imaging System IYO - System, Imaging, Pulsed Echo, Ultrasonic RA 892.1570 Diagnostic Ultrasonic Transducer ITX - Transducer, Ultrasonic, Diagnostic Diagnostic X-Ray Imaging Devices (except mammographic x-ray systems): RA 892.1600 Angiographic X-Ray System IZI - System, X-Ray, Angiographic RA 892.1650 Image-Intensified Fluoroscopic X-Ray System MQB - Solid State X-Ray Imager (Flat Panel/Digital Imager) JAA - System, X-Ray, Fluoroscopic, Image-Intensified RA 892.1680 Stationary X-Ray System KPR - System, X-Ray, Stationary RA 892.1720 Mobile X-Ray System IZL - System, X-Ray, Mobile RA 892.1740 Tomographic X-Ray System IZF - System, X-Ray, Tomographic RA 892.1750 Computed Tomography X-Ray System JAK - System, X-Ray, Tomography, Computed ECG-Related Devices: CV 870.2340 Electrocardiograph DPS - Electrocardiograph MLC - Monitor, ST Segment CV 870.2350 Electrocardiograph Lead Switching Adaptor DRW - Adaptor, Lead Switching, Electrocardiograph CV 870.2360 Electrocardiograph Electrode DRX - Electrode, Electrocardiograph CV 870.2370 Electrocardiograph Surface Electrode Tester KRC - Tester, Electrode, Surface, Electrocardiographic NE 882.1400 Electroencephalograph GWQ - Electroencephalograph HO 880.5725 Infusion Pump (external only) MRZ - Accessories, Pump, Infusion FRN - Pump, Infusion LZF - Pump, Infusion, Analytical Sampling MEB - Pump, Infusion, Elastomeric LZH - Pump, Infusion, Enteral MHD - Pump, Infusion, Gallstone Dissolution LZG - Pump, Infusion, Insulin MEA - Pump, Infusion, PCA Ophthalmic Instruments: OP 886.1570 Ophthalmoscope HLI - Ophthalmoscope, AC-Powered HLJ - Ophthalmoscope, Battery-Powered OP 886.1780 Retinoscope HKL - Retinoscope, AC-Powered OP 886.1850 AC-Powered Slit-Lamp Biomicroscope HJO - Biomicroscope, Slit-Lamp, AC-Powered OP 886.4150 Vitreous Aspiration and Cutting Instrument MMC - Dilator, Expansive Iris (Accessory) HQE - Instrument, Vitreous Aspiration and Cutting, AC-Powered HKP - Instrument, Vitreous Aspiration and Cutting, Battery-Powered MLZ - Vitrectomy, Instrument Cutter OP 886.4670 Phacofragmentation System HQC - Unit, Phacofragmentation SU 878.4580 Surgical Lamp HBI - Illuminator, Fiberoptic, Surgical Field FTF - Illuminator, Nonremote FTG - Illuminator, Remote HJE - Lamp, Fluorescein, AC-Powered FQP - Lamp, Operating-Room FTD - Lamp, Surgical GBC - Lamp, Surgical, Incandescent FTA - Light, Surgical, Accessories FSZ - Light, Surgical, Carrier FSY - Light, Surgical, Ceiling Mounted FSX - Light, Surgical, Connector FSW - Light, Surgical, Endoscopic FST - Light, Surgical, Fiberoptic FSS - Light, Surgical, Floor Standing FSQ - Light, Surgical, Instrument NE 882.5890 Transcutaneous Electrical Nerve Stimulator for Pain Relief GZJ - Stimulator, Nerve, Transcutaneous, For Pain Relief Noninvasive Blood Pressure Measurement Devices: CV 870.1120 Blood Pressure Cuff DXQ - Cuff, Blood-Pressure CV 870.1130 Noninvasive Blood Pressure Measurement System (except nonoscillometric) DXN - System, Measurement, Blood-Pressure, Noninvasive HO 880.6880 Steam Sterilizer (greater than 2 cubic feet) FLE - Sterilizer, Steam Clinical Thermometers: HO 880.2910 Clinical Electronic Thermometer (except tympanic or pacifier) FLL - Thermometer, Electronic, Clinical AN 868.5630 Nebulizer CAF - Nebulizer (Direct Patient Interface) Hypodermic Needles and Syringes (except antistick and self-destruct): HO 880.5570 Hypodermic Single Lumen Needle MMK - Container, Sharpes FMI - Needle, Hypodermic, Single Lumen MHC - Port, Intraosseous, Implanted HO 880.5860 Piston Syringe FMF - Syringe, Piston Selected Dental Materials: DE 872.3060 Gold-Based Alloys and Precious Metal Alloys for Clinical Use EJT - Alloy, Gold Based, For Clinical Use EJS - Alloy, Precious Metal, For Clinical Use DE 872.3200 Resin Tooth Bonding Agent KLE - Agent, Tooth Bonding, Resin DE 872.3275 Dental Cement EMA - Cement, Dental EMB - Zinc Oxide Eugenol DE 872.3660 Impression Material ELW - Material, Impression DE 872.3690 Tooth Shade Resin Material EBF - Material, Tooth Shade, Resin DE 872.3710 Base Metal Alloy EJH - Metal, Base Latex Condoms: OB 884.5300 Condom HIS - Condom Table 3 - Medical Devices for Possible Inclusion in Scope of Product Coverage During Operational Period1
Product Family 21 CFR Section No Device Name Tier Anesthesiology Panel Anesthesia Devices 868.5160 Gas machine for anesthesia or analgesia 2 868.5270 Breathing system heater 2 868.5440 Portable oxygen generator 2 868.5450 Respiratory gas humidifier 2 868.5630 Nebulizer 2 868.5710 Electrically powered oxygen tent 2 868.5880 Anesthetic vaporizer 2 Gas Analyser 868.1040 Powered Algesimeter 2 868.1075 Argon gas analyzer 2 868.1400 Carbon dioxide gas analyzer 2 868.1430 Carbon monoxide gas analyzer 2 868.1500 Enflurane gas analyzer 2 868.1620 Halothane gas analyzer 2 868.1640 Helium gas analyzer 2 868.1670 Neon gas analyzer 2 868.1690 Nitrogen gas analyzer 2 868.1700 Nitrous oxide gas analyzer 2 868.1720 Oxygen gas analyzer 2 868.1730 Oxygen uptake computer 2 Peripheral Nerve Stimulators 868.2775 Electrical peripheral nerve stimulator 2 Respiratory Monitoring 868.1750 Pressure plethysmograph 2 868.1760 Volume plethysmograph 2 868.1780 Inspiratory airway pressure meter 2 868.1800 Rhinoanemometer 2 868.1840 Diagnostic spirometer 2 868.1850 Monitoring spirometer 2 868.1860 Peak-flow meter for spirometry 2 868.1880 Pulmonary-function data calculator 2 868.1890 Predictive pulmonary-function value calculator 2 868.1900 Diagnostic pulmonary-function interpretation calculator 2 868.2025 Ultrasonic air embolism monitor 2 868.2375 Breathing frequency monitor (except apnea detectors) 2 868.2480 Cutaneous carbon dioxide (PcCO2) monitor 2 868.2500 Cutaneous oxygen monitor (for an infant not under gas anesthesia) 2 868.2550 Pneumotachomometer 2 868.2600 Airway pressure monitor 2 868.5665 Powered percussor 2 868.5690 Incentive spirometer 2 Ventilator 868.5905 Noncontinuous ventilator (IPPB) 2 868.5925 Powered emergency ventilator 2 868.5935 External negative pressure ventilator 2 868.5895 Continuous ventilator 2 868.5955 Intermittent mandatory ventilation attachment 2 868.6250 Portable air compressor 2 Cardiovascular Panel Cardiovascular Diagnostic 870.1425 Programmable diagnostic computer 2 870.1450 Densitometer 2 870.2310 Apex cardiograph (vibrocardiograph) 2 870.2320 Ballistocardiograph 2 870.2340 Electrocardiograph 2 870.2350 Electrocardiograph lead switching adaptor 1 870.2360 Electrocardiograph electrode 2 870.2370 Electrocardiograph surface electrode tester 2 870.2400 Vectorcardiograph 1 870.2450 Medical cathode-ray tube display 1 870.2675 Oscillometer 2 870.2840 Apex cardiographic transducer 2 870.2860 Heart sound transducer 2 Cardiovascular Monitoring Valve, pressure relief, cardiopulmonary bypass 870.1100 Blood pressure alarm 2 870.1110 Blood pressure computer 2 870.1120 Blood pressure cuff 2 870.1130 Noninvasive blood pressure measurement system 2 870.1140 Venous blood pressure manometer 2 870.1220 Electrode recording catheter or electrode recording probe 2 870.1270 Intracavitary phonocatheter system 2 870.1875 Stethoscope (electronic) 2 870.2050 Biopotential amplifier and signal conditioner 2 870.2060 Transducer signal amplifier and conditioner 2 870.2100 Cardiovascular blood flow-meter 2 870.2120 Extravascular blood flow probe 2 870.2300 Cardiac monitor (including cardiotachometer and rate alarm) 2 870.2700 Oximeter 2 870.2710 Ear oximeter 2 870.2750 Impedance phlebograph 2 870.2770 Impedance plethysmograph 2 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs 2 870.2850 Extravascular blood pressure transducer 2 870.2870 Catheter tip pressure transducer 2 870.2880 Ultrasonic transducer 2 870.2890 Vessel occlusion transducer 2 870.2900 Patient transducer and electrode cable (including connector) 2 870.2910 Radiofrequency physiological signal transmitter and receiver 2 870.2920 Telephone electrocardiograph transmitter and receiver 2 870.4205 Cardiopulmonary bypass bubble detector 2 870.4220 Cardiopulmonary bypass heart-lung machine console 2 870.4240 Cardiovascular bypass heat exchanger 2 870.4250 Cardiopulmonary bypass temperature controller 2 870.4300 Cardiopulmonary bypass gas control unit 2 870.4310 Cardiopulmonary bypass coronary pressure gauge 2 870.4330 Cardiopulmonary bypass on-line blood gas monitor 2 870.4340 Cardiopulmonary bypass level sensing monitor and/or control 2 870.4370 Roller-type cardiopulmonary bypass blood pump 2 870.4380 Cardiopulmonary bypass pump speed control 2 870.4410 Cardiopulmonary bypass in-line blood gas sensor 2 Cardiovascular Therapeutic 870.5050 Patient care suction apparatus 2 870.5900 Thermal regulation system 2 Defibrillator 870.5300 DC-defibrillator (including paddles) 2 870.5325 Defibrillator tester 2 Echocardiograph 870.2330 Echocardiograph 2 Pacemaker & Accessories 870.1750 External programmable pacemaker pulse generator 2 870.3630 Pacemaker generator function analyzer 2 870.3640 Indirect pacemaker generator function analyzer 2 870.3720 Pacemaker electrode function tester 2 Miscellaneous 870.1800 Withdrawal-infusion pump 2 870.2800 Medical magnetic tape recorder 2 None Batteries, rechargeable, class II devices Dental Panel Dental Equipment 872.1720 Pulp tester 2 872.1740 Caries detection device 2 872.4120 Bone cutting instrument and accessories 2 872.4465 Gas-powered jet injector 2 872.4475 Spring-powered jet injector 2 872.4600 Intraoral ligature and wire lock 2 872.4840 Rotary scaler 2 872.4850 Ultrasonic scaler 2 872.4920 Dental electrosurgical unit and accessories 2 872.6070 Ultraviolet activator for polymerization 2 872.6350 Ultraviolet detector 2 Dental Material 872.3050 Amalgam alloy 2 872.3060 Gold-based alloys and precious metal alloys for clinical use 2 872.3200 Resin tooth bonding agent 2 872.3250 Calcium hydroxide cavity liner 2 872.3260 Cavity varnish 2 872.3275 Dental cement (other than zinc oxide-eugenol) 2 872.3300 Hydrophilic resin coating for dentures 2 872.3310 Coating material for resin fillings 2 872.3590 Preformed plastic denture tooth 2 872.3660 Impression material 2 872.3690 Tooth shade resin material 2 872.3710 Base metal alloy 2 872.3750 Bracket adhesive resin and tooth conditioner 2 872.3760 Denture relining, repairing, or rebasing resin 2 872.3765 Pit and fissure sealant and conditioner 2 872.3770 Temporary crown and bridge resin 2 872.3820 Root canal filling resin (other than chloroform use) 2 872.3920 Porcelain tooth 2 Dental X-ray 872.1800 Extraoral source x-ray system 2 872.1810 Intraoral source x-ray system 2 Dental Implants 872.4880 Intraosseous fixation screw or wire 2 872.3890 Endodontic stabilizing splint 2 Orthodontic 872.5470 Orthodontic plastic bracket 2 Ear/Nose/Throat Panel Diagnostic Equipment 874.1050 Audiometer 2 874.1090 Auditory impedance tester 2 874.1120 Electronic noise generator for audiometric testing 2 874.1325 Electroglottograph 2 874.1820 Surgical nerve stimulator/locator 2 Hearing Aids 874.3300 Hearing aid (for bone-conduction) 2 874.3310 Hearing aid calibrator and analysis system 2 874.3320 Group hearing aid or group auditory trainer 2 874.3330 Master hearing aid 2 Surgical Equipment 874.4250 Ear, nose, and throat electric or pneumatic surgical drill 1 874.4490 Argon laser for otology, rhinology, and laryngology 2 874.4500 Ear, nose, and throat microsurgical carbon dioxide laser 2 Gastroenterology/Urology Panel Endoscope (including angioscopes, laparscopes, ophthalmic endoscopes) 876.1500 Endoscope and accessories 2 876.4300 Endoscopic electrosurgical unit and accessories 2 Gastroenterology 876.1725 Gastrointestinal motility monitoring system 1 Hemodialysis 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis 2 876.5630 Peritoneal dialysis system and accessories 2 876.5665 Water purification system for hemodialysis 2 876.5820 Hemodialysis system and accessories 2 876.5830 Hemodialyzer with disposable insert (kiil-type) 2 Lithotriptor 876.4500 Mechanical lithotriptor 2 Urology Equipment 876.1620 Urodynamics measurement system 2 876.5320 Nonimplanted electrical continence device 2 876.5880 Isolated kidney perfusion and transport system and accessories 2 General Hospital Panel Infusion Pumps and Systems 880.2420 Electronic monitor for gravity flow infusion systems 2 880.2460 Electrically powered spinal fluid pressure monitor 2 880.5430 Nonelectrically powered fluid injector 2 880.5725 Infusion pump 2 Neonatal Incubators 880.5400 Neonatal incubator 2 880.5410 Neonatal transport incubator 2 880.5700 Neonatal phototherapy unit 2 Piston Syringes 880.5570 Hypodermic single lumen needle 1 880.5860 Piston syringe (except antistick) 1 880.6920 Syringe needle introducer 2 Miscellaneous 880.2910 Clinical electronic thermometer 2 880.2920 Clinical mercury thermometer 2 880.5100 AC-powered adjustable hospital bed 1 880.5500 AC-powered patient lift 2 880.6880 Steam sterilizer (greater than 2 cubic feet) 2 Neurology Panel 882.1020 Rigidity analyzer 2 882.1610 Alpha monitor 2 Neuro-Diagnostic 882.1320 Cutaneous electrode 2 882.1340 Nasopharyngeal electrode 2 882.1350 Needle electrode 2 882.1400 Electroencephalograph 2 882.1460 Nystagmograph 2 882.1480 Neurological endoscope 2 882.1540 Galvanic skin response measurement device 2 882.1550 Nerve conduction velocity measurement device 2 882.1560 Skin potential measurement device 2 882.1570 Powered direct-contact temperature measurement device 2 882.1620 Intracranial pressure monitoring device 2 882.1835 Physiological signal amplifier 2 882.1845 Physiological signal conditioner 2 882.1855 Electroencephalogram (EEG) telemetry system 2 882.5050 Biofeedback device 2 Echoencephalography 882.1240 Echoencephalograph 2 RPG 882.4400 Radiofrequency lesion generator 2 Neuro Surgery none Electrode, spinal epidural 2 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories 2 882.4310 Powered simple cranial drills burrs, trephines, and their accessories 2 882.4360 Electric cranial drill motor 2 882.4370 Pneumatic cranial drill motor 2 882.4560 Stereotaxic instrument 2 882.4725 Radiofrequency lesion probe 2 882.4845 Powered rongeur 2 882.5500 Lesion temperature monitor 2 Stimulators 882.1870 Evoked response electrical stimulator 2 882.1880 Evoked response mechanical stimulator 2 882.1890 Evoked response photic stimulator 2 882.1900 Evoked response auditory stimulator 2 882.1950 Tremor transducer 2 882.5890 Transcutaneous electrical nerve stimulator for pain relief 2 Obstetrics/Gynecology Panel Fetal Monitoring 884.1660 Transcervical endoscope (amnioscope) and accessories 2 884.1690 Hysteroscope and accessories (for performance standards) 2 884.2225 Obstetric-gynecologic ultrasonic imager 2 884.2600 Fetal cardiac monitor 2 884.2640 Fetal phonocardiographic monitor and accessories 2 884.2660 Fetal ultrasonic monitor and accessories 2 884.2675 Fetal scalp circular (spiral) electrode and applicator 1 884.2700 Intrauterine pressure monitor and accessories 2 884.2720 External uterine contraction monitor and accessories 2 884.2740 Perinatal monitoring system and accessories 2 884.2960 Obstetric ultrasonic transducer and accessories 2 Gynecological Surgery Equipment 884.1720 Gynecologic laparoscope and accessories 2 884.4160 Unipolar endoscopic coagulator-cutter and accessories 2 884.4550 Gynecologic surgical laser 2 884.4120 Gynecologic electrocautery and accessories 2 884.5300 Condom 2 Ophthalmic Implants 886.3320 Eye sphere implant 2 Contact Lens 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens 2 886.5916 Rigid gas permeable contact lens (daily wear only) 2 Diagnostic Equipment 886.1120 Opthalmic camera 1 886.1220 Corneal electrode 1 886.1250 Euthyscope (AC-powered) 1 886.1360 Visual field laser instrument 1 886.1510 Eye movement monitor 1 886.1570 Ophthalmoscope 1 886.1630 AC-powered photostimulator 1 886.1640 Ophthalmic preamplifier 1 886.1670 Ophthalmic isotope uptake probe 2 886.1780 Retinoscope (AC-powered device) 1 886.1850 AC-powered slit lamp biomicroscope 1 886.1930 Tonometer and accessories 2 886.1945 Transilluminator (AC-powered device) 1 886.3130 Ophthalmic conformer 2 (Diagnostic/Surgery Equipment) 886.4670 Phacofragmentation system 2 Ophthalmic Implants 886.3340 Extraocular orbital implant 2 886.3800 Scleral shell 2 Surgical Equipment 880.5725 Infusion pump (performance standards) 2 886.3100 Ophthalmic tantalum clip 2 886.3300 Absorbable implant (scleral buckling method) 2 886.4100 Radiofrequency electrosurgical cautery apparatus 2 886.4115 Thermal cautery unit 2 886.4150 Vitreous aspiration and cutting instrument 2 886.4170 Cryophthalmic unit 2 886.4250 Ophthalmic electrolysis unit (AC-powered device) 1 886.4335 Operating headlamp (AC-powered device) 1 886.4390 Ophthalmic laser 2 886.4392 Nd:YAG laser for posterior capsulotomy 2 886.4400 Electronic metal locator 1 886.4440 AC-powered magnet 1 886.4610 Ocular pressure applicator 2 886.4690 Ophthalmic photocoagulator 2 886.4790 Ophthalmic sponge 2 886.5100 Ophthalmic beta radiation source 2 none Ophthalmoscopes, replacement batteries, hand-held 1 Orthopedic Panel Implants 888.3010 Bone fixation cerclage 2 888.3020 Intramedullary fixation rod 2 888.3030 Single/multiple component metallic bone fixation appliances and accessories 2 888.3040 Smooth or threaded metallic bone fixation fastener 2 888.3050 Spinal interlaminal fixation orthosis 2 888.3060 Spinal intervertebral body fixation orthosis 2 Surgical Equipment 888.1240 AC-powered dynamometer 2 888.4580 Sonic surgical instrument and accessories/attachments 2 none Accessories, fixation, spinal interlaminal 2 none Accessories, fixation, spinal intervertebral body 2 none Monitor, pressure, intracompartmental 1 none Orthosis, fixation, spinal intervertebral fusion 2 none Orthosis, spinal pedicle fixation none System, cement removal extraction 1 Physical Medicine Panel Diagnostic Equipment or (Therapy) Therapeutic Equipment 890.1225 Chronaximeter 2 890.1375 Diagnostic electromyograph 2 890.1385 Diagnostic electromyograph needle electrode 2 890.1450 Powered reflex hammer 2 890.1850 Diagnostic muscle stimulator 2 or (Therapy) 890.5850 Powered muscle stimulator 2 Therapeutic Equipment 890.5100 Immersion hydrobath 2 890.5110 Paraffin bath 2 890.5500 Infrared lamp 2 890.5720 Water circulating hot or cold pack 2 890.5740 Powered heating pad 2 Radiology Panel MRI 892.1000 Magnetic resonance diagnostic device 2 Ultrasound Diagnostic 884.2660 Fetal ultrasonic monitor and accessories 2 892.1540 Nonfetal ultrasonic monitor 892.1560 Ultrasonic pulsed echo imaging system 2 892.1570 Diagnostic ultrasonic transducer 2 892.1550 Ultrasonic pulsed doppler imaging system Angiographic 892.1600 Angiographic x-ray system 2 Diagnostic X-Ray 892.1610 Diagnostic x-ray beam-limiting device 2 892.1620 Cine or spot fluorographic x-ray camera 2 892.1630 Electrostatic x-ray imaging system 2 892.1650 Image-intensified fluoroscopic x-ray system 2 892.1670 Spot film device 2 892.1680 Stationary x-ray system 2 892.1710 Mammographic x-ray system 2 892.1720 Mobile x-ray system 2 892.1740 Tomographic x-ray system 1 892.1820 Pneumoencephalographic chair 2 892.1850 Radiographic film cassette 1 892.1860 Radiographic film/cassette changer 1 892.1870 Radiographic film/cassette changer programmer 2 892.1900 Automatic radiographic film processor 2 892.1980 Radiologic table 1 CT Scanner 892.1750 Computed tomography x-ray system 2 Radiation Therapy 892.5050 Medical charged-particle radiation therapy system 2 892.5300 Medical neutron radiation therapy system 2 892.5700 Remote controlled radionuclide applicator system 2 892.5710 Radiation therapy beam-shaping block 2 892.5730 Radionuclide brachytherapy source 2 892.5750 Radionuclide radiation therapy system 2 892.5770 Powered radiation therapy patient support assembly 2 892.5840 Radiation therapy simulation system 2 892.5930 Therapeutic x-ray tube housing assembly 1 Nuclear Medicine 892.1170 Bone densitometer 2 892.1200 Emission computed tomography system 2 892.1310 Nuclear tomography system 1 892.1390 Radionuclide rebreathing system 2 General/Plastic Surgery Panel Surgical Lamps 878.4630 Ultraviolet lamp for dermatologic disorders 2 890.5500 Infrared lamp 2 878.4580 Surgical lamp 2 Electrosurgical Cutting Equipment 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology 2 878.4400 Electrosurgical cutting and coagulation device and accessories 2 Miscellaneous 878.4780 Powered suction pump 2 [63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999]