510(k) K141481

TRC-NW400 NON-MYDRIATIC RETINAL CAMERA by Topcon Corporation — Product Code HKI

K141481 is an FDA 510(k) premarket notification submitted by Topcon Corporation for the device "TRC-NW400 NON-MYDRIATIC RETINAL CAMERA". The FDA issued a decision of Substantially Equivalent on September 17, 2014. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Topcon Corporation has at least 10 other 510(k) clearances on record.