MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT

MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT is an FDA 510(k)-cleared medical device (K973712) manufactured by Minxray, 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 December 11, 1997. Regulation: 8.