Radiological / Joint Photographic Experts Group / / /
Event
FDA Phase / / /
IndustryTerm
contrast imaging drugs / computer-assisted detection device / accessory equipment / communications system / hardcopy devices / software platform / contrast imaging agent / diagnostic devices / communications devices / i.e. product / magnetic resonance imaging / computer-triage devices / predicate device / communications systems / digital data storage devices / software components / short term surveillance imaging / digital processing / cleared devices / imaging / add-on software / i . e .ii . e ..i . e .ei . e ..i . e . i . e .pi . e .ri . e .oi . e .di . e .ui . e .ci . e .ti . e . / /
MedicalCondition
disease / diseases / /
Organization
U.S. Department of Health and Human Services / Food and Drug Administration / Division of Dockets Management / FDA / Imaging and Applied Mathematics office of Science / Society of Motion Picture and Television Engineers / Radiological Devices Office / /
Person
Joyce Whang / Nicholas Petrick / / /
Position
General Information In accordance with / Governor / family practice physician / nurse / physician / General / /
Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions