NFJClass II

System, Image Management, Ophthalmic

21 CFR 892.2050 / Radiology

NFJ is the FDA product code for System, Image Management, Ophthalmic, a class II device type, regulated under 21 CFR 892.2050. As of 2026-09-10, FDA records hold 53 510(k) clearances under this code, the most recent dated 2026-07-17, and 14 recalls.

Classification record

Product code: NFJ
Device name: System, Image Management, Ophthalmic
Regulation: 21 CFR 892.2050
Device class: Class II
Review panel: Radiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 53
Ingested recalls: 14

Clearances, product code NFJ

By decision year

53 clearances under product code NFJ with a decision year between 2002 and 2026, 2018 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code NFJ by decision year
Year	Clearances
2002	1
2007	1
2008	1
2009	4
2011	2
2012	2
2013	5
2014	2
2015	3
2017	5
2018	7
2019	2
2020	5
2021	2
2022	3
2023	4
2024	2
2026	2

Applicants with the most clearances

Product code NFJ

Applicants holding the most 510(k) clearances under product code NFJ
Applicant	Clearances
Carl Zeiss Meditec Inc	13
Topcon Healthcare, Inc.	5
Topcon Corp.	3
Huvitz Co., Ltd.	2
Konan Medical, Inc.	2
Topcon Healthcare Solutions	2
Topcon Healthcare Solutions EMEA Oy	2
Altris, Inc.	1
Canon Inc. -Medical Equipment Group	1
Canon, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order