FDA Product Code
FDA Product Code PIB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1100
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253704 | iPredict-DR | iHealthscreen, Inc. | 2026-07-02 | Traditional | PDF ↗ |
| K240058 | AEYE-DS | Aeye Health, Inc. | 2024-04-23 | Traditional | PDF ↗ |
| K223357 | EyeArt v2.2.0 | Eyenuk, Inc. | 2023-06-16 | Traditional | PDF ↗ |
| K221183 | AEYE-DS | Aeye Health, Inc. | 2022-11-10 | Traditional | PDF ↗ |
| K213037 | IDx-DR v2.3 | Digital Diagnostics, Inc. | 2022-06-17 | Traditional | PDF ↗ |
| K203629 | IDx-DR | Digital Diagnostics, Inc. | 2021-06-10 | Traditional | PDF ↗ |
| K200667 | EyeArt | Eyenuk, Inc. | 2020-08-03 | Traditional | PDF ↗ |
| DEN180001 | IDx-DR | Idx, LLC | 2018-04-11 | Direct | — |
Product code PIB · Class II · Ophthalmic. Data: openFDA.