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FDA 510(k)

Canon OCT-A1

K-Number: K182942 · 2019-07-24

ApplicantCanon, Inc.
Decision Date2019-07-24
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Canon OCT-A1 is a medical device manufactured by Canon, Inc.. It received FDA 510(k) clearance on 2019-07-24 under approval number K182942. 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 Canon OCT-A1?

Canon OCT-A1 is a medical device that received FDA 510(k) clearance on 2019-07-24. It is manufactured by Canon, Inc.. The 510(k) number is K182942.

When was Canon OCT-A1 approved by the FDA?

Canon OCT-A1 received FDA 510(k) clearance on 2019-07-24, under approval number K182942.

What company makes Canon OCT-A1?

Canon OCT-A1 is manufactured by Canon, Inc..

What is the FDA product code for Canon OCT-A1?

The FDA product code for Canon OCT-A1 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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