BIOK7600W Wireless Flat Panel Detector

BIOK7600W Wireless Flat Panel Detector is an FDA 510(k)-cleared medical device (K190300) manufactured by Biokinemetrics, 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 12, 2019. Regulation: 8.