FDA product code NFI: Device, Hardcopy, Images, Ophthalmic
NFI is the FDA product code for device, hardcopy, images, ophthalmic. It is a Class II device, regulated under 21 CFR 892.2040 and reviewed by the Ophthalmic panel. Devices under NFI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Device, Hardcopy, Images, Ophthalmic |
| Device class | Class II |
| Regulation | 21 CFR 892.2040 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Recalls for NFI devices
openFDA lists no recalls for product code NFI.
Frequently asked questions
What is FDA product code NFI?
NFI is the FDA product code for device, hardcopy, images, ophthalmic. It is a Class II device, regulated under 21 CFR 892.2040 and reviewed by the Ophthalmic panel.
What device class is NFI?
Class II, regulation 21 CFR 892.2040. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NFI
- Run a recall and safety report across every NFI manufacturer
- Watch product code NFI 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.