ClearanceBrief
510(k) K240417 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

ProFound Detection (V4.0)

ApplicantIcad, Inc., Nashua NH, US
DecisionSubstantially Equivalent, Nov 8, 2024
ReceivedFeb 13, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K240417

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.