ClearanceBrief
510(k) K231195 ยท QAS Radiological Computer-Assisted Triage And Notification Software

Brainomix 360 Triage ICH

ApplicantBrainomix Limited, Oxford, GB
DecisionSubstantially Equivalent, Jul 27, 2023
ReceivedApr 27, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K231195

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.