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FDA 510(k)

IMAGENET 5 PC SOFTWARE SYSTEM

K-Number: K132438 · 2013-10-17

ApplicantTopcon Medical Systems, Inc.
Decision Date2013-10-17
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGENET 5 PC SOFTWARE SYSTEM 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 2013-10-17 under 510(k) number K132438. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGENET 5 PC SOFTWARE SYSTEM?

IMAGENET 5 PC SOFTWARE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-17. The listed applicant is Topcon Medical Systems, Inc.. The 510(k) number is K132438.

When did IMAGENET 5 PC SOFTWARE SYSTEM receive FDA 510(k) clearance?

IMAGENET 5 PC SOFTWARE SYSTEM received FDA 510(k) clearance on 2013-10-17, under 510(k) number K132438.

Who is the listed applicant for IMAGENET 5 PC SOFTWARE SYSTEM?

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 IMAGENET 5 PC SOFTWARE SYSTEM?

The FDA product code for IMAGENET 5 PC SOFTWARE SYSTEM is NFJ.

Related Clinical Trials

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Other records listing Topcon Medical Systems, Inc. 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.

K182376HarmonyK132667SYNERGY ODMK123101TRC-50DX RETINAL CAMERAK123460TRC-NW300 NON-MYDRIATIC RETINAL CAMERAK110489SLIT LAMP SL-2GK093313SYNERGY

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Related Devices (Code: NFJ)

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.

K260694ZEISS CLINIC 360Carl Zeiss Meditec, AGK253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA OyK234076iCare ALTIUS CWCentervue S.P.A.K232828IMAGEnet6 Ophthalmic Data SystemTopcon CorporationK232944CALLISTO eyeCarl Zeiss Meditec, AGK232555HarmonyTopcon Healthcare Solutions

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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