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FDA 510(k)

Image Filing Software NAVIS-EX

K-Number: K181345 · 2018-07-19

ApplicantNidek Co., Ltd.
Decision Date2018-07-19
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Image Filing Software NAVIS-EX is the device name listed in this FDA 510(k) record. The listed applicant is Nidek Co., Ltd.. It received FDA 510(k) clearance on 2018-07-19 under 510(k) number K181345. 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 Image Filing Software NAVIS-EX?

Image Filing Software NAVIS-EX is a medical device that received FDA 510(k) clearance on 2018-07-19. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K181345.

When did Image Filing Software NAVIS-EX receive FDA 510(k) clearance?

Image Filing Software NAVIS-EX received FDA 510(k) clearance on 2018-07-19, under 510(k) number K181345.

Who is the listed applicant for Image Filing Software NAVIS-EX?

The FDA 510(k) record lists Nidek Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Image Filing Software NAVIS-EX?

The FDA product code for Image Filing Software NAVIS-EX is NFJ.

Other records listing Nidek Co., Ltd. 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.

K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EXK203130Ophthalmic Yag Laser System YC-200K192045Ophthalmic Yag Laser System YC-200K190198Microperimeter MP-3, Microperimeter MP-3 Type SK173980Specular Microscope CEM-530PMA P970053Excimer laser system

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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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