ClearanceBrief
510(k) K261713 ยท QIH Automated Radiological Image Processing Software

Synapse PACS (7.6.0)

ApplicantFUJIFILM Healthcare Americas Corporation, Lexington MA, US
DecisionSubstantially Equivalent, Jun 18, 2026
ReceivedMay 22, 2026
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K261713

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.