FDA 510(k) Applications for Medical Device Product Code "PIB"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K221183 | AEYE Health, Inc. | AEYE-DS | 11/10/2022 |
| K203629 | Digital Diagnostics Inc. | IDx-DR | 06/10/2021 |
| K213037 | Digital Diagnostics Inc. | IDx-DR v2.3 | 06/17/2022 |
| K200667 | Eyenuk, Inc | EyeArt | 08/03/2020 |
| K223357 | Eyenuk, Inc. | EyeArt v2.2.0 | 06/16/2023 |
| DEN180001 | IDx, LLC | IDx-DR | 04/11/2018 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
