7 devices · 6 companies · 2018 to 2024
Product code PIB: Diabetic Retinopathy Detection Device
7 devices under product code PIB, 2018 to 2024, from 6 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (7 of 7 here), the regulation, and MAUDE report counts by product code.
Diabetic Retinopathy Detection Device. 21 CFR 886.1100, Class II. 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. MAUDE held 1 adverse-event report against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| AEYE-DSK240058 · 510(k) | AEYE Health Inc. | Ophthalmic | database entry | |
| EyeArt v2.2.0K223357 · 510(k) | Eyenuk, Inc. | Ophthalmic | database entry | |
| AEYE-DSK221183 · 510(k) | AEYE Health, Inc. | Ophthalmic | database entry | |
| IDx-DR v2.3K213037 · 510(k) | Digital Diagnostics Inc. | Ophthalmic | database entry | |
| IDx-DRK203629 · 510(k) | Digital Diagnostics Inc. | Ophthalmic | database entry | |
| EyeArtK200667 · 510(k) | Eyenuk, Inc | Ophthalmic | database entry | |
| IDx-DRDEN180001 · De Novo | IDx, LLC | Ophthalmic | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.