ROTATING GAMMA SYSTEM INFINI (INFINI)

ROTATING GAMMA SYSTEM INFINI (INFINI) is an FDA 510(k)-cleared medical device (K102533) manufactured by Masep Medical Science & Tech.Development (Shenzhen. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 21, 2011. Regulation: 8.