PI808 MOBILE C-ARM IMAGE INTENSIFIER

PI808 MOBILE C-ARM IMAGE INTENSIFIER is an FDA 510(k)-cleared medical device (K820178) manufactured by Precise Optics. 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 3, 1982. Regulation: 8.