10 devices · 9 companies · 2018 to 2025
AI-enabled ophthalmic devices on FDA's list
10 devices in the Ophthalmic panel, 2018 to 2025, from 9 companies across 3 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (10 of 10 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes in the Ophthalmic panel
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Product code | FDA |
|---|---|---|---|---|
| CLARUSK243878 · 510(k) | Carl Zeiss Meditec, Inc. | QER | database entry | |
| Notal Vision Home Optical Coherence TomographyDEN230043 · De Novo | Notal Vision Inc | SAX | database entry | |
| AEYE-DSK240058 · 510(k) | AEYE Health Inc. | PIB | database entry | |
| EyeArt v2.2.0K223357 · 510(k) | Eyenuk, Inc. | PIB | database entry | |
| AEYE-DSK221183 · 510(k) | AEYE Health, Inc. | PIB | database entry | |
| IDx-DR v2.3K213037 · 510(k) | Digital Diagnostics Inc. | PIB | database entry | |
| IDx-DRK203629 · 510(k) | Digital Diagnostics Inc. | PIB | database entry | |
| EyeArtK200667 · 510(k) | Eyenuk, Inc | PIB | database entry | |
| CLARUSK191194 · 510(k) | Carl Zeiss Meditec, Inc | QER | database entry | |
| IDx-DRDEN180001 · De Novo | IDx, LLC | PIB | database entry |
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.