
Canon USA, Inc.
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CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM is an FDA 510(k)-cleared medical device (K862323) manufactured by Canon USA, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 20, 1986. Regulation: 8.

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