510(k) K241081

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System by Topcon Corporation — Product Code OBO

K241081 is an FDA 510(k) premarket notification submitted by Topcon Corporation for the device "3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System". The FDA issued a decision of Substantially Equivalent on July 17, 2024. The device falls under product code OBO (Tomography, Optical Coherence), a Class II device regulated under 21 CFR 886.1570. Topcon Corporation has at least 10 other 510(k) clearances on record.