FDA product code · Ophthalmic · Class 2
NFJ: System, Image Management, Ophthalmic
NFJ is FDA's product code for "System, Image Management, Ophthalmic": a Class 2 device classified under 21 CFR 892.2050, reviewed by the Ophthalmic panel.
510(k) review time for NFJ
Across 27 510(k) clearances under NFJ decided from 2018-01-01 to 2026-10-06, the median was 92 days from FDA receipt to decision. Half took between 59 and 198 days, and 80% were decided within 215 days. These are past clearances, not a forecast for a new submission.
| Fastest | 18 |
|---|---|
| 25th percentile | 59 |
| Median | 92 |
| 75th percentile | 198 |
| 80th percentile | 215 |
| 90th percentile | 261 |
| Slowest | 329 |
| Year | Median days | n |
|---|---|---|
| 2018 | 84 | 7 |
| 2020 | 116 | 5 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
NFJ in the public FDA record
| 510(k) clearances, all years | 53 |
|---|---|
| Device recalls | 14 |
Counts of records, not of devices or events. Adverse event reports for NFJ are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite NFJ
2 FDA recognized consensus standards cite NFJ, among them NEMA PS 3.1 - 3.20 2024e; NEMA PS 3.1 - 3.20 2025d. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-363 NEMA PS 3.1 - 3.20 2024e — Digital Imaging and Communications in Medicine (DICOM) Set
- 12-385 NEMA PS 3.1 - 3.20 2025d — Digital Imaging and Communications in Medicine (DICOM) Set
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.