# Perimeter Medical Imaging Ai, Inc.: PMA supplement approved for Claire™ OCT System

**Score:** 30/100

| Field | Value |
|---|---|
| Sponsor | Perimeter Medical Imaging Ai, Inc. |
| Product | Claire™ OCT System |
| Generic / ingredient | OCT imaging system with AI/ML software for adjunctive detection of breast cancer |
| Approval | PMA supplement (device change) |
| Application | P250008 S001 |
| Decided | 2026-08-10 |
| Panel / class | General, Plastic Surgery |
| Sponsor location | Toronto |

## Why this score


Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250008S001). Last refreshed: 2026-11-05T08:47:15.055Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.