K203629 is an FDA 510(k) clearance for the IDx-DR. This device is classified as a Diabetic Retinopathy Detection Device (Class II - Special Controls, product code PIB).
Submitted by Digital Diagnostics, Inc. (Coralville, US). The FDA issued a Cleared decision on June 10, 2021, 181 days after receiving the submission on December 11, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1100. A Retinal Diagnostic Software Device Is A Prescription Software Device That Incorporates An Adaptive Algorithm To Evaluate Ophthalmic Images For Diagnostic Screening To Identify Retinal Diseases Or Conditions..
| 510(k) Number | K203629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2020 |
| Decision Date | June 10, 2021 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | PIB - Diabetic Retinopathy Detection Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1100 |
| Definition | A Retinal Diagnostic Software Device Is A Prescription Software Device That Incorporates An Adaptive Algorithm To Evaluate Ophthalmic Images For Diagnostic Screening To Identify Retinal Diseases Or Conditions. |