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FDA 510(k)

RETINA CAMERA TRC-NW7SF MARK II

K-Number: K090115 · 2009-06-30

ApplicantTopcon Corp.
Decision Date2009-06-30
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RETINA CAMERA TRC-NW7SF MARK II is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corp.. It received FDA 510(k) clearance on 2009-06-30 under 510(k) number K090115. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETINA CAMERA TRC-NW7SF MARK II?

RETINA CAMERA TRC-NW7SF MARK II is a medical device that received FDA 510(k) clearance on 2009-06-30. The listed applicant is Topcon Corp.. The 510(k) number is K090115.

When did RETINA CAMERA TRC-NW7SF MARK II receive FDA 510(k) clearance?

RETINA CAMERA TRC-NW7SF MARK II received FDA 510(k) clearance on 2009-06-30, under 510(k) number K090115.

Who is the listed applicant for RETINA CAMERA TRC-NW7SF MARK II?

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 RETINA CAMERA TRC-NW7SF MARK II?

The FDA product code for RETINA CAMERA TRC-NW7SF MARK II is HKI.

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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-2000K082364IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FORK063388TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEMK041367TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA

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Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

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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