1. Computer-assisted detection devices applied to radiology images and radiology device data: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, September 28, 2022 Subject(s): Diagnosis, Computer-AssistedDevice ApprovalGovernment RegulationRadiographic Image Interpretation, Computer-AssistedUnited StatesUnited States. Food and Drug Administration
