510(k) K111791

LUMAGEM MOLECULAR BREAST IMAGING SYSTEM by Gamma Medica-Ideas Incorporated — Product Code IYX

K111791 is an FDA 510(k) premarket notification submitted by Gamma Medica-Ideas Incorporated for the device "LUMAGEM MOLECULAR BREAST IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 23, 2011. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Gamma Medica-Ideas Incorporated has at least 1 other 510(k) clearance on record.