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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 a medical device manufactured by Nidek Co., Ltd.. It received FDA 510(k) clearance on 2018-07-19 under approval 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. It is manufactured by Nidek Co., Ltd.. The 510(k) number is K181345.

When was Image Filing Software NAVIS-EX approved by the FDA?

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

What company makes Image Filing Software NAVIS-EX?

Image Filing Software NAVIS-EX is manufactured by Nidek Co., Ltd..

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

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

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Related PubMed Literature

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Other Devices by Nidek Co., Ltd.

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Related Devices (Code: NFJ)

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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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