DeviceClearance

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

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.

Clearance details

Applicant
Topcon Corporation
Product code
Code OBO
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Itabashi-Ku, JP
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.