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Medicatech USA
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DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 is an FDA 510(k)-cleared medical device (K082798) manufactured by Medicatech USA. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 27, 2008. Regulation: 8.