§ 892.2050 - Medical image management and processing system.

§ 892.2050 Picture archiving and communications Medical image management and processing system.

(a) Identification. A picture archiving and communications medical image management and processing system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, review and digital processing of medical images . Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devicesfor the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for performing operations related to image manipulation, enhancement, compression or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

(b) Classification. Class II (special controls; voluntary standards - Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

[63 FR 23387, Apr. 29, 1998, as amended at 86 FR 20284, Apr. 19, 2021]