ClearanceBrief
510(k) K221624 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Avenda Health AI Prostate Cancer Planning Software

ApplicantAvenda Health, Inc., Culver City CA, US
DecisionSubstantially Equivalent, Nov 22, 2022
ReceivedJun 6, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K221624

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.