https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-assisted-detection-devices-applied-radiology-images-and-radiology-device-data-premarket
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data -...
This guidance provides recommendations regarding 510(k) submissions for computer-assisted detection (CADe) devices applied to radiology images and radiology...
computer assisted detectiondevicesapplied