Claire™ OCT System is an AI-enabled medical device from Perimeter Medical Imaging Ai, Inc., listed by FDA (PMA, P250008) with a decision date of 2026-03-03. Review panel: General and Plastic Surgery.
| FDA submission number | P250008 |
|---|---|
| Pathway | PMA |
| Company | Perimeter Medical Imaging Ai, Inc. |
| Review panel (specialty) | General and Plastic Surgery |
| FDA decision date | 2026-03-03 |
| Product code | SHH |
| Classification | Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer |
| Device class | 3 |
| Review time (calendar days) | 355 |
Official FDA database record · FDA AI-enabled device list
All General and Plastic Surgery AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.