Oncology
Claire OCT System
Perimeter Medical Imaging AI, Inc.
FDA
FDA-cleared AI medical device
AI-enabled wide-field optical-coherence-tomography system that images excised breast-tissue specimens intraoperatively to assist surgeons in assessing margins during breast-conserving surgery.
FDA Submission Metadata
- Submission number
- P250008
- Decision date
- March 2026
- FDA panel
- General and Plastic Surgery
- Product code
- SHH
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA