PMA
P250008: Claire™ OCT System
FDA PMA · OCT imaging system with AI/ML software for adjunctive detection of breast cancer · Perimeter Medical Imaging Ai, Inc.
Key facts
| PMA number | P250008 |
|---|---|
| Trade name | Claire™ OCT System |
| Generic name | OCT imaging system with AI/ML software for adjunctive detection of breast cancer |
| Applicant | Perimeter Medical Imaging Ai, Inc. |
| Owner/operator | Perimeter Medical Imaging AI |
| Product code | SHH |
| Approval date | Mar 3, 2026 |
| Establishment registration | 3013276158 |
| FEI number | 3013276158 |
At a glance
- 1–9 Supplements
- Aug 10, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: