FDA 510(k)

CIRRUS HD-OCT

K-Number: K222200 · 2023-04-13

Decision Date2023-04-13

Product CodeOBO

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

CIRRUS HD-OCT is a medical device manufactured by Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2023-04-13 under approval number K222200. 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 CIRRUS HD-OCT?

CIRRUS HD-OCT is a medical device that received FDA 510(k) clearance on 2023-04-13. It is manufactured by Carl Zeiss Meditec, Inc.. The 510(k) number is K222200.

When was CIRRUS HD-OCT approved by the FDA?

CIRRUS HD-OCT received FDA 510(k) clearance on 2023-04-13, under approval number K222200.

What company makes CIRRUS HD-OCT?

CIRRUS HD-OCT is manufactured by Carl Zeiss Meditec, Inc..

What is the FDA product code for CIRRUS HD-OCT?

The FDA product code for CIRRUS HD-OCT is OBO.

Other Devices by Carl Zeiss Meditec, Inc.

K161194PLEX Elite 9000 SS-OCT K182318Retina Workplace K173371VisuMax Femtosecond Laser K191194CLARUS K181534CIRRUS HD-OCT K181444CLARUS

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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.