HITACHI TECH-MOBLE DHC-121

HITACHI TECH-MOBLE DHC-121 is an FDA 510(k)-cleared medical device (K780313) manufactured by Philips Medical Systems (Cleveland), Inc.. 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 13, 1978. Regulation: 8.