INFINTT CO., LTD. STARPACS SYSTEM

INFINTT CO., LTD. STARPACS SYSTEM is an FDA 510(k)-cleared medical device (K031013) manufactured by Infinitt Company. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 16, 2003. Regulation: 8.