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FDA 510(k)

TRC-NW300 NON-MYDRIATIC RETINAL CAMERA

K-Number: K123460 · 2013-02-06

ApplicantTopcon Medical Systems, Inc.
Decision Date2013-02-06
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TRC-NW300 NON-MYDRIATIC RETINAL CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Medical Systems, Inc.. It received FDA 510(k) clearance on 2013-02-06 under 510(k) number K123460. 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 TRC-NW300 NON-MYDRIATIC RETINAL CAMERA?

TRC-NW300 NON-MYDRIATIC RETINAL CAMERA is a medical device that received FDA 510(k) clearance on 2013-02-06. The listed applicant is Topcon Medical Systems, Inc.. The 510(k) number is K123460.

When did TRC-NW300 NON-MYDRIATIC RETINAL CAMERA receive FDA 510(k) clearance?

TRC-NW300 NON-MYDRIATIC RETINAL CAMERA received FDA 510(k) clearance on 2013-02-06, under 510(k) number K123460.

Who is the listed applicant for TRC-NW300 NON-MYDRIATIC RETINAL CAMERA?

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

What is the FDA product code for TRC-NW300 NON-MYDRIATIC RETINAL CAMERA?

The FDA product code for TRC-NW300 NON-MYDRIATIC RETINAL CAMERA is HKI.

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Other records listing Topcon Medical Systems, Inc. as applicant

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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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