510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141325Substantially Equivalent

Trc-Nw8f Plus Non-Mydriatic Retinal Camera

Topcon Corp., North Reading MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141325 is the FDA 510(k) clearance record for TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA, a class II device, cleared for Topcon Corp. on under FDA product code HKI (Camera, Ophthalmic, Ac-Powered). FDA records list 22 510(k) clearances for Topcon Corp., from to . As of , FDA records show no recalls naming K141325.

Clearance record

Decision date
Received
(156 days to decision)
Product code
HKI Camera, Ophthalmic, Ac-Powered
Regulation
21 CFR 886.1120
Device class
Class II
Review panel
Ophthalmic
Applicant
Topcon Corp. 5 Timber Ln., North Reading MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HKI

Trailing 12 months
3 clearances under product code HKI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HKI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260