510(k) K203629
- Device
- IDx-DR
- Applicant
- Digital Diagnostics Inc.
- 510(k) number
- K203629
- Product code
- PIB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-06-10
- Date received
- 2020-12-11
- Regulation
- 886.1100
- Classification name
- Diabetic Retinopathy Detection Device
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ashley Miller
- Address
- 2300 Oakdale Blvd. Coralville IA US 52241 52241
FDA Registration Numbers#
- 3014579028
- 3025301728
- 3013924858
Source Documents#
Other 510(k) Records For Product Code PIB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240058 | AEYE-DS | Aeye Health, Inc. | 2024-04-23 |
| K223357 | EyeArt v2.2.0 | Eyenuk, Inc. | 2023-06-16 |
| K221183 | AEYE-DS | Aeye Health, Inc. | 2022-11-10 |
| K213037 | IDx-DR v2.3 | Digital Diagnostics, Inc. | 2022-06-17 |
| K200667 | EyeArt | Eyenuk, Inc. | 2020-08-03 |
| DEN180001 | IDx-DR | Idx, LLC | 2018-04-11 |
Legacy Summary#
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FDA Review#
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