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FDA 510(k)

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

K-Number: K231222 · 2023-10-30

ApplicantTopcon Corporation
Decision Date2023-10-30
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) is a medical device manufactured by Topcon Corporation. It received FDA 510(k) clearance on 2023-10-30 under approval number K231222. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)?

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) is a medical device that received FDA 510(k) clearance on 2023-10-30. It is manufactured by Topcon Corporation. The 510(k) number is K231222.

When was 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) approved by the FDA?

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) received FDA 510(k) clearance on 2023-10-30, under approval number K231222.

What company makes 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)?

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) is manufactured by Topcon Corporation.

What is the FDA product code for 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)?

The FDA product code for 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) is OBO.

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Related Devices (Code: OBO)

K162783EnFocus 2300, EnFocus 4400Bioptigen, Inc. K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. K1615093D OCT-1 MaestroTopcon Corporation K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith MulticolorHeidelberg Engineering GmbH K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with MulticolorHeidelberg Engineering GmbH K163195PRIMUSCarl Zeiss Suzhou Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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