IDx-DR
FDA 510(k) clearance DEN180001 · decided 2018-04-11
Clearance details
- K-number
- DEN180001
- Device name
- IDx-DR
- Applicant
- Idx, LLC
- Decision
- Unknown
- Date received
- 2018-01-12
- Decision date
- 2018-04-11
- Days to decision
- 89 days
- Clearance type
- Direct
- Product code
- PIB
- Device class
- 2
- Regulation number
- 886.1100
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Iowa City, IA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| iPredict-DR (K253704) | iHealthscreen, Inc. | 2026-07-02 |
| AEYE-DS (K240058) | Aeye Health, Inc. | 2024-04-23 |
| EyeArt v2.2.0 (K223357) | Eyenuk, Inc. | 2023-06-16 |
| AEYE-DS (K221183) | Aeye Health, Inc. | 2022-11-10 |
| IDx-DR v2.3 (K213037) | Digital Diagnostics, Inc. | 2022-06-17 |
| IDx-DR (K203629) | Digital Diagnostics, Inc. | 2021-06-10 |
| EyeArt (K200667) | Eyenuk, Inc. | 2020-08-03 |
Recalls involving this device
No recalls on record reference this clearance.