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FDA 510(k)

Spectralis HRA+OCT and variants with High Magnification Module

K-Number: K182569 · 2018-10-18

ApplicantHeidelberg Engineering GmbH
Decision Date2018-10-18
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Spectralis HRA+OCT and variants with High Magnification Module is a medical device manufactured by Heidelberg Engineering GmbH. It received FDA 510(k) clearance on 2018-10-18 under approval number K182569. 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 Spectralis HRA+OCT and variants with High Magnification Module?

Spectralis HRA+OCT and variants with High Magnification Module is a medical device that received FDA 510(k) clearance on 2018-10-18. It is manufactured by Heidelberg Engineering GmbH. The 510(k) number is K182569.

When was Spectralis HRA+OCT and variants with High Magnification Module approved by the FDA?

Spectralis HRA+OCT and variants with High Magnification Module received FDA 510(k) clearance on 2018-10-18, under approval number K182569.

What company makes Spectralis HRA+OCT and variants with High Magnification Module?

Spectralis HRA+OCT and variants with High Magnification Module is manufactured by Heidelberg Engineering GmbH.

What is the FDA product code for Spectralis HRA+OCT and variants with High Magnification Module?

The FDA product code for Spectralis HRA+OCT and variants with High Magnification Module is OBO.

Other Devices by Heidelberg Engineering GmbH

K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor K181594Spectralis HRA+OCT and variants with OCT Angiography Module K173648Spectralis HRA + OCT and variants K192391Spectralis HRA+OCT and Variants K201252Spectralis HRA+OCT and variants

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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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