
Bio-Scan S.A
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SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW is an FDA 510(k)-cleared medical device (K013897) manufactured by Bio-Scan S.A. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 20, 2002. Regulation: 8.