510(k) K111731

MOLECULAR BREAST IMAGING SOFTWARE by Gamma Medica-Ideas Incorporated — Product Code LLZ

K111731 is an FDA 510(k) premarket notification submitted by Gamma Medica-Ideas Incorporated for the device "MOLECULAR BREAST IMAGING SOFTWARE". The FDA issued a decision of Substantially Equivalent on September 15, 2011. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Gamma Medica-Ideas Incorporated has at least 1 other 510(k) clearance on record.