Panels › Ophthalmic › Product code PIB · Class 2
Diabetic Retinopathy Detection Device
Regulation 886.1100
1510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PIB
| Company | 510(k)s | Recalls |
|---|---|---|
| Aeye Health, Inc. | 2 | 0 |
| Digital Diagnostics, Inc. | 2 | 0 |
| Eyenuk, Inc. | 2 | 0 |
| Idx, LLC | 1 | 0 |
| iHealthscreen, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 2, 2026 | K253704 | iPredict-DR iHealthscreen, Inc. | PIB |
| Apr 23, 2024 | K240058 | AEYE-DS Aeye Health, Inc. | PIB |
| Jun 16, 2023 | K223357 | EyeArt v2.2.0 Eyenuk, Inc. | PIB |
| Nov 10, 2022 | K221183 | AEYE-DS Aeye Health, Inc. | PIB |
| Jun 17, 2022 | K213037 | IDx-DR v2.3 Digital Diagnostics, Inc. | PIB |
| Jun 10, 2021 | K203629 | IDx-DR Digital Diagnostics, Inc. | PIB |
| Aug 3, 2020 | K200667 | EyeArt Eyenuk, Inc. | PIB |
| Apr 11, 2018 | DEN180001 | IDx-DR Idx, LLC | PIB |
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