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Non-Mydriatic Auto Fundus Camera Afc-330 with Image Filing Software Na Vis-Ex

by Nidek Technologies SRL

510(k) K113451

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113451 Date8 May 2012ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1980-2014 FDA Class II initiated 16 Jun 2014

    Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.

    • Terminated Z-2046-2013 FDA Class II initiated 1 Aug 2013

    Under certain circumstances, the Left eye image may be saved as the Right eye image.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HKI
Device Class
Class II
Regulation
21 CFR Part 886.1120
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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