510(k) K232828

IMAGEnet6 Ophthalmic Data System by Topcon Corporation — Product Code NFJ

K232828 is an FDA 510(k) premarket notification submitted by Topcon Corporation for the device "IMAGEnet6 Ophthalmic Data System". The FDA issued a decision of Substantially Equivalent on March 1, 2024. 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.