K240058 is an FDA 510(k) clearance for the AEYE-DS. This device is classified as a Diabetic Retinopathy Detection Device (Class II - Special Controls, product code PIB).
Submitted by Aeye Health, Inc. (New York, US). The FDA issued a Cleared decision on April 23, 2024, 106 days after receiving the submission on January 8, 2024.
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 | K240058 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2024 |
| Decision Date | April 23, 2024 |
| Days to Decision | 106 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. |