ClearanceBrief
510(k) K111791 ยท IYX Camera, Scintillation (Gamma)

LUMAGEM MOLECULAR BREAST IMAGING SYSTEM

ApplicantGamma Medica-Ideas Incorporated, Sunnyvale CA, US
DecisionSubstantially Equivalent, Sep 23, 2011
ReceivedJun 27, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K111791

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.