NFJ
- Product code
- NFJ
- Device name
- System, Image Management, Ophthalmic
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.2050
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 6
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 53 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260694 | 2026-07-17 | Carl Zeiss Meditec, AG | ZEISS CLINIC 360 | |
| K253893 | 2026-06-04 | Topcon Healthcare Solutions EMEA Oy | Harmony Referral System with Harmony OCT Viewer (Oct… | |
| K234076 | 2024-08-22 | Centervue S.P.A. | iCare ALTIUS CW | |
| K232828 | 2024-03-01 | Topcon Corporation | IMAGEnet6 Ophthalmic Data System | |
| K232944 | 2023-12-21 | Carl Zeiss Meditec, AG | CALLISTO eye | |
| K232555 | 2023-11-20 | Topcon Healthcare Solutions | Harmony |
Official FDA classification page: NFJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).