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Digital Healthcare, Ltd.
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IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP is an FDA 510(k)-cleared medical device (K071299) manufactured by Digital Healthcare, Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2007. Regulation: 8.