ClearanceBrief
510(k) K211611 ยท QIH Automated Radiological Image Processing Software

QIR Suite

ApplicantCasis Cardiac Simulation & Imaging Software, Quetigny, FR
DecisionSubstantially Equivalent, Sep 30, 2022
ReceivedMay 25, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K211611

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.