510(k) K031629

CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI by Canon USA, Inc. — Product Code HKI

K031629 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI". The FDA issued a decision of Substantially Equivalent on June 6, 2003. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Canon USA, Inc. has at least 10 other 510(k) clearances on record.