PIB — Diabetic Retinopathy Detection Device Class II
FDA product code PIB covers "Diabetic Retinopathy Detection Device", a Class II medical device regulated under 21 CFR 886.1100. Submissions are reviewed by the Ophthalmic panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PIB
- Device Class
- Class II
- Regulation Number
- 886.1100
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253704 | Ihealthscreen | iPredict-DR | Jul 2, 2026 |
| K240058 | Aeye Health | AEYE-DS | Apr 23, 2024 |
| K223357 | Eyenuk | EyeArt v2.2.0 | Jun 16, 2023 |
| K221183 | Aeye Health | AEYE-DS | Nov 10, 2022 |
| K213037 | Digital Diagnostics | IDx-DR v2.3 | Jun 17, 2022 |
| K203629 | Digital Diagnostics | IDx-DR | Jun 10, 2021 |
| K200667 | Eyenuk | EyeArt | Aug 3, 2020 |
| DEN180001 | Idx | IDx-DR | Apr 11, 2018 |