On 22 January 2020 the U.S. Food and Drug Administration
(FDA or the agency) published three regulations formally
classifying certain radiological image analyzers and related
software, including computer-assisted/aided detection (CADe), as
class II medical devices subject to 510(k) premarket notification
with special controls. FDA also formally codified two CAD
device types (radiological computer-assisted diagnostic (CADx)
software and radiological computer aided triage and notification
software (CADt)) addressed through De Novo Requests as class II
devices and provided detailed classification regulations, including
special controls, for such products going forward.
On 22 January 2020 the U.S. Food and Drug Administration (FDA or
the agency) published three regulations formally classifying
certain radiological image analyzers and related software,
including computer-assisted/aided detection (CADe), as class II
medical devices subject to 510(k) premarket notification
