Image Filing Software NAVIS-EX— 510(k) K181345

Substantially Equivalent

Nidek Co., Ltd.

FDA 510(k) clearance K181345 for Image Filing Software NAVIS-EX, Substantially Equivalent on 2018-07-19. Applicant: Nidek Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nidek Co., Ltd.
Product code: Code NFJ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2018-05-21
Decision date: 2018-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gamagori, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.