510(k) K873075

ADAC MODEL ARC-5000, GAMMA CAMERA by Adac Laboratories — Product Code JWM

K873075 is an FDA 510(k) premarket notification submitted by Adac Laboratories for the device "ADAC MODEL ARC-5000, GAMMA CAMERA". The FDA issued a decision of Substantially Equivalent on October 30, 1987. The device falls under product code JWM (System, Tomographic, Nuclear), a Class II device regulated under 21 CFR 892.1310. Adac Laboratories has at least 10 other 510(k) clearances on record.