ClearanceBrief
510(k) K101868 ยท OWB Interventional Fluoroscopic X-Ray System

INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V

ApplicantToshiba America Medical Systems, In.C, Tustin CA, US
DecisionSubstantially Equivalent, Sep 7, 2010
ReceivedJul 2, 2010
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K101868

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.