510(k) K171370

IMAGEnet 6 Ophthalmic Data System by Topcon Corporation — Product Code NFJ

K171370 is an FDA 510(k) premarket notification submitted by Topcon Corporation for the device "IMAGEnet 6 Ophthalmic Data System". The FDA issued a decision of Substantially Equivalent on November 1, 2017. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050. Topcon Corporation has at least 10 other 510(k) clearances on record.