510(k) K160933

Discovery NM 750b Bopsy by GE Healthcare — Product Code IYX

K160933 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "Discovery NM 750b Bopsy". The FDA issued a decision of Substantially Equivalent on November 18, 2016. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. GE Healthcare has at least 10 other 510(k) clearances on record.