PIB — Diabetic Retinopathy Detection Device Class II
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 |
|---|---|---|---|
| K240058 | aeye health | AEYE-DS | April 23, 2024 |
| K223357 | eyenuk | EyeArt v2.2.0 | June 16, 2023 |
| K221183 | aeye health | AEYE-DS | November 10, 2022 |
| K213037 | digital diagnostics | IDx-DR v2.3 | June 17, 2022 |
| K203629 | digital diagnostics | IDx-DR | June 10, 2021 |
| K200667 | eyenuk | EyeArt | August 3, 2020 |
| DEN180001 | idx | IDx-DR | April 11, 2018 |