ClearanceBrief
510(k) K260584 ยท QIH Automated Radiological Image Processing Software

BoneMRI

ApplicantMriguidance B.V., Utrecht, NL
DecisionSubstantially Equivalent, Aug 21, 2026
ReceivedFeb 20, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260584

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.