Perimeter Medical Imaging Ai, Inc.
FDA 510(k) & PMA Approved Devices — 2 products
Total Devices2
Categories2
Latest FDA decision2026-08-10
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P250008 | OCT imaging system with AI/ML software for adjunctive detection of breast cancer | SHH | 2026-08-10 | View |
| 510(k) | K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System | NQQ | 2021-02-25 | View |
No matching devices.