510(k) DEN180001
- Device
- IDx-DR
- Applicant
- Idx, LLC
- 510(k) number
- DEN180001
- Product code
- PIB
- Decision
- Unknown (DENG)
- Decision date
- 2018-04-11
- Date received
- 2018-01-12
- Regulation
- 886.1100
- Classification name
- Diabetic Retinopathy Detection Device
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Michael D. Abramoff
- Address
- 458 Hwy. 1 W. Iowa City IA US 52246 52246
FDA Registration Numbers#
- 3014579028
- 3025301728
- 3013924858
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K203629 | IDx-DR | Digital Diagnostics, Inc. | 2021-06-10 |
| K200667 | EyeArt | Eyenuk, Inc. | 2020-08-03 |