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FDA 510(k)

TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM

K-Number: K063388 · 2007-06-22

ApplicantTopcon Corp.
Decision Date2007-06-22
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corp.. It received FDA 510(k) clearance on 2007-06-22 under 510(k) number K063388. 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 TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM?

TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-06-22. The listed applicant is Topcon Corp.. The 510(k) number is K063388.

When did TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM receive FDA 510(k) clearance?

TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM received FDA 510(k) clearance on 2007-06-22, under 510(k) number K063388.

Who is the listed applicant for TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM?

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

What is the FDA product code for TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM?

The FDA product code for TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM is OBO.

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Other records listing Topcon Corp. 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.

K130289TRC-NW8 NON-MYDRIATIC RETINAL CAMERAK100207NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8FK092470OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000K090115RETINA CAMERA TRC-NW7SF MARK IIK082364IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FORK041367TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA

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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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