510(k) K201122

Canon non-mydriatic retinal camera CR series by Canon, Inc. — Product Code HKI

K201122 is an FDA 510(k) premarket notification submitted by Canon, Inc. for the device "Canon non-mydriatic retinal camera CR series". The FDA issued a decision of Substantially Equivalent on July 23, 2020. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Canon, Inc. has at least 10 other 510(k) clearances on record.