ClearanceBrief
510(k) K254131 ยท QIH Automated Radiological Image Processing Software

BAC

ApplicantDeepHealth, Inc., Somerville MA, US
DecisionSubstantially Equivalent, May 21, 2026
ReceivedDec 22, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K254131

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.