FDA product code NFJ: System, Image Management, Ophthalmic
NFJ is the FDA product code for system, image management, ophthalmic. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Ophthalmic panel. FDA has cleared 53 510(k) submissions under NFJ, 11 in the last five years, from 33 different applicants. The average 510(k) review took 124 days (median 107); 184 days on average over the last three years. FDA has posted 14 recalls for NFJ devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Image Management, Ophthalmic |
| Device class | Class II |
| Regulation | 21 CFR 892.2050 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NFJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 156 |
| 2018 | 7 | 79 |
| 2019 | 2 | 31 |
| 2020 | 5 | 123 |
| 2021 | 2 | 220 |
| 2022 | 3 | 276 |
| 2023 | 4 | 70 |
| 2024 | 2 | 208 |
| 2026 | 2 | 159 |
Compare with all 510(k) review times · Search every NFJ clearance
Top NFJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carl Zeiss Meditec, AG | 11 | 2026-07-17 |
| Topcon Medical Systems, Inc. | 5 | 2018-09-28 |
| Topcon Healthcare Solutions EMEA Oy | 2 | 2026-06-04 |
| Topcon Corporation | 2 | 2024-03-01 |
| Konan Medical, Inc. | 2 | 2021-06-15 |
28 more applicants have NFJ clearances. See the full list in Caduvo.
Most recent NFJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260694 | Carl Zeiss Meditec, AG | ZEISS CLINIC 360 | 2026-07-17 | 136 |
| K253893 | Topcon Healthcare Solutions EMEA Oy | Harmony Referral System with Harmony OCT Viewer (Octave) | 2026-06-04 | 182 |
| K234076 | Centervue S.P.A. | iCare ALTIUS CW | 2024-08-22 | 245 |
| K232828 | Topcon Corporation | IMAGEnet6 Ophthalmic Data System | 2024-03-01 | 170 |
| K232944 | Carl Zeiss Meditec, AG | CALLISTO eye | 2023-12-21 | 92 |
Recalls for NFJ devices
14 product recalls in 13 recall events; 3 initiated in the last five years and 2 still open. Most recent: 2025-09-09.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2019 | 1 |
| 2020 | 2 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code NFJ?
NFJ is the FDA product code for system, image management, ophthalmic. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Ophthalmic panel.
What device class is NFJ?
Class II, regulation 21 CFR 892.2050. Typical premarket route: 510(k).
How long does a 510(k) take for product code NFJ?
Across 53 cleared submissions the average was 124 days from receipt to decision (median 107).
Which companies have the most NFJ clearances?
Carl Zeiss Meditec, AG (11); Topcon Medical Systems, Inc. (5); Topcon Healthcare Solutions EMEA Oy (2); Topcon Corporation (2); Konan Medical, Inc. (2).
Have NFJ devices been recalled?
Yes: 14 product recalls across 13 recall events; the most recent began 2025-09-09.
Next steps
- Run an FDA pathway report with predicate devices for product code NFJ
- Run a recall and safety report across every NFJ manufacturer
- Watch product code NFJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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