510(k) K102231

DISCOVERY NM 750B by Ge Medical Systems Israel, Functional Imaging — Product Code IYX

K102231 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Israel, Functional Imaging for the device "DISCOVERY NM 750B". The FDA issued a decision of Substantially Equivalent on November 3, 2010. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Ge Medical Systems Israel, Functional Imaging has at least 3 other 510(k) clearances on record.