2020-00497. Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer  

Document Information

Effective Date:
1/22/2020
Published:
01/22/2020
Department:
Health and Human Services Department
Agency:
Food and Drug Administration
EntryType:
Rule
Action:
Final amendment; final order.
Document Number:
2020-00497
Dates:
This order is effective January 22, 2020. The classification was applicable on July 19, 2017.
Pages:
3540-3543 (4 pages)
Docket Numbers:
Docket No. FDA-2019-N-5610
SectionNoes:
892.2060
Topics:
Medical devices, Radiation protection, X-rays
PDF File:
2020-00497.pdf
CFR: (1)
21 CFR 892.2060