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FDA 510(k)

HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT

K-Number: K063191 · 2006-10-31

ApplicantHeidelberg Engineering
Decision Date2006-10-31
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT is the device name listed in this FDA 510(k) record. The listed applicant is Heidelberg Engineering. It received FDA 510(k) clearance on 2006-10-31 under 510(k) number K063191. 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 HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT?

HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT is a medical device that received FDA 510(k) clearance on 2006-10-31. The listed applicant is Heidelberg Engineering. The 510(k) number is K063191.

When did HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT receive FDA 510(k) clearance?

HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT received FDA 510(k) clearance on 2006-10-31, under 510(k) number K063191.

Who is the listed applicant for HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT?

The FDA 510(k) record lists Heidelberg Engineering as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT?

The FDA product code for HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT is OBO.

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Other records listing Heidelberg Engineering as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K101223SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FAK052935HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)K042742HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)K971671HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)K943956RETINA TOMOGRAPH AND FLOWMETERK943955RETINA FLOWMETER

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Related Devices (Code: OBO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261019ANTERIONHeidelberg Engineering GmbHK253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbHK252633UNITY DX (UDX)Cylite Pty. , Ltd.K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey CorporationK250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbHK240924AnterionHeidelberg Engineering GmbH

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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