SHH · Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer
· Class 3
Overview
| Product Code | SHH |
|---|---|
| Device Name | Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer |
| Device Class | Class 3 |
| Review Panel |
Identification
Intended as an adjunctive tool for intraoperative imaging and detection of cancer in breast tissue during excisional breast surgery (e.g., lumpectomy).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P250008 | Claire OCT System | Perimeter Medical Imaging Ai, Inc. | Mar 3, 2026 | APPR |
Top Applicants
- Perimeter Medical Imaging Ai, Inc. — 1 clearance
