
Ophthalmic Technologies, Inc.
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OTI SCAN WITH TRANSDUCERS is an FDA 510(k)-cleared medical device (K030770) manufactured by Ophthalmic Technologies, 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 26, 2003. Regulation: 8.