3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System— 510(k) K241081

Name: FDA 510(k) clearance K241081
Creator: U.S. Food and Drug Administration
Published: 2024-07-17

Substantially Equivalent

Topcon Corporation

FDA 510(k) clearance K241081 for 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System, Substantially Equivalent on 2024-07-17. Applicant: Topcon Corporation. Device class: 2.

Clearance details

Applicant: Topcon Corporation
Product code: Code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2024-04-19
Decision date: 2024-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Itabashi-Ku, JP

Download summary PDF View on FDA.gov ↗

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