FDA 510(k)

3D OCT-1 Maestro

K-Number: K170164 · 2017-03-03

Decision Date2017-03-03

Product CodeOBO

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

3D OCT-1 Maestro is a medical device manufactured by Topcon Corporation. It received FDA 510(k) clearance on 2017-03-03 under approval number K170164. 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 OCT-1 Maestro?

3D OCT-1 Maestro is a medical device that received FDA 510(k) clearance on 2017-03-03. It is manufactured by Topcon Corporation. The 510(k) number is K170164.

When was 3D OCT-1 Maestro approved by the FDA?

3D OCT-1 Maestro received FDA 510(k) clearance on 2017-03-03, under approval number K170164.

What company makes 3D OCT-1 Maestro?

3D OCT-1 Maestro is manufactured by Topcon Corporation.

What is the FDA product code for 3D OCT-1 Maestro?

The FDA product code for 3D OCT-1 Maestro is OBO.

Other Devices by Topcon Corporation

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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.