IDx-DR
Diabetic Retinopathy Detection Device
Digital Diagnostics Inc.
The following data is part of a premarket notification filed by Digital Diagnostics Inc. with the FDA for Idx-dr.
Pre-market Notification Details
| Device ID | K203629 |
| 510k Number | K203629 |
| Device Name: | IDx-DR |
| Classification | Diabetic Retinopathy Detection Device |
| Applicant | Digital Diagnostics Inc. 2300 Oakdale Blvd. Coralville, IA 52241 |
| Contact | Ashley Miller |
| Correspondent | Ashley Miller Digital Diagnostics Inc. 2300 Oakdale Blvd. Coralville, IA 52241 |
| Product Code | PIB |
| CFR Regulation Number | 886.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-11 |
| Decision Date | 2021-06-10 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860005195619 | K203629 | 000 |
Trademark Results [IDx-DR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IDX-DR 88065421 5877563 Live/Registered |
IDX TECHNOLOGIES, INC. 2018-08-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.