NFJ — System, Image Management, Ophthalmic Class II
FDA product code NFJ covers "System, Image Management, Ophthalmic", a Class II medical device regulated under 21 CFR 892.2050. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NFJ
- Device Class
- Class II
- Regulation Number
- 892.2050
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260694 | carl zeiss meditec | ZEISS CLINIC 360 | July 17, 2026 |
| K253893 | topcon healthcare solutions emea | Harmony Referral System with Harmony OCT Viewer (Octave) | June 4, 2026 |
| K234076 | centervue | iCare ALTIUS CW | August 22, 2024 |
| K232828 | topcon corporation | IMAGEnet6 Ophthalmic Data System | March 1, 2024 |
| K232944 | carl zeiss meditec | CALLISTO eye | December 21, 2023 |
| K232555 | topcon healthcare solutions | Harmony | November 20, 2023 |
| K231676 | carl zeiss meditec | CALLISTO eye | August 28, 2023 |
| K232088 | altris | Altris IMS | July 31, 2023 |
| K220929 | merit cro | Excelsior | October 31, 2022 |
| K213527 | carl zeiss meditec | FORUM | August 15, 2022 |
| K211715 | retinai medical | RetinAI Discovery | April 28, 2022 |
| K210396 | topcon healthcare solutions emea | Harmony Referral System | September 13, 2021 |
| K203244 | konan medical | CellChek 20 rc | June 15, 2021 |
| K200422 | visionquest biomedical | Image Quality Analyzer (IQA) | December 24, 2020 |
| K201273 | canon | ImageSPECTRUM | September 25, 2020 |
| K200954 | topcon healthcare solutions | Glaucoma Module | August 3, 2020 |
| K200385 | integrated ophthalmic systems | CONTINUUM PACS | March 16, 2020 |
| K200275 | ophthalmic labs | OVision Imaging System | March 3, 2020 |
| K191615 | huvitz co | Huvitz Imaging System | July 18, 2019 |
| K190056 | kowa co. ltd. chofu | KOWA VK-2s | February 12, 2019 |