OPHTHASCAN 'S' MINI-A

OPHTHASCAN 'S' MINI-A is an FDA 510(k)-cleared medical device (K893035) manufactured by Biophysic Medical, 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 June 11, 1989. Regulation: 8.