The following data is part of a premarket notification filed by Digital Diagnostics Inc. with the FDA for Idx-dr V2.3.
| Device ID | K213037 |
| 510k Number | K213037 |
| Device Name: | IDx-DR V2.3 |
| Classification | Diabetic Retinopathy Detection Device |
| Applicant | Digital Diagnostics Inc. 2300 Oakdale Blvd Coralville, IA 52241 |
| Contact | Ashley Miller |
| Correspondent | Kelliann Payne Hogan Lovells US LLP 1735 Market St., Floor 23 Philadelphia, PA 19103 |
| Product Code | PIB |
| CFR Regulation Number | 886.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-21 |
| Decision Date | 2022-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860005195626 | K213037 | 000 |