510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181345Substantially Equivalent

Image Filing Software NAVIS-EX

Nidek Co., Ltd., Gamagori, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181345 is the FDA 510(k) clearance record for Image Filing Software NAVIS-EX, a class II device, cleared for Nidek Co., Ltd. on under FDA product code NFJ (System, Image Management, Ophthalmic). FDA records list 12 510(k) clearances for Nidek Co., Ltd., from to . As of , FDA records show no recalls naming K181345.

Clearance record

Decision date
Received
(59 days to decision)
Product code
NFJ System, Image Management, Ophthalmic
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Nidek Co., Ltd. 34-14 Maehama, Gamagori, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFJ

Trailing 12 months
2 clearances under product code NFJ in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NFJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260