PMA P250008
- Device
- Claire™ OCT System
- Applicant
- Perimeter Medical Imaging Ai, Inc.
- PMA number
- P250008
- Product code
- SHH
- Decision date
- 2026-03-03
- Classification
- General, Plastic Surgery
- Generic name
- OCT imaging system with AI/ML software for adjunctive detection of breast cancer
- Approval order statement
- The Claire OCT System is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer-aided detection algorithm which identifies and marks focal areas suspicious for breast cancer and is used concurrently with physician interpretation of the images. The Claire OCT System is intended for use in conjunction with other standard methods for evaluation of the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.
Current openFDA PMA Record#
- Device
- Claire™ OCT System
- Applicant
- Perimeter Medical Imaging Ai, Inc.
- PMA number
- P250008
- Product code
- SHH
- Generic name
- OCT imaging system with AI/ML software for adjunctive detection of breast cancer
- Decision date
- 2026-03-03
- Decision code
- APPR
- Date received
- 2025-03-13
- Approval order statement
- The Claire OCT System is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer-aided detection algorithm which identifies and marks focal areas suspicious for breast cancer and is used concurrently with physician interpretation of the images. The Claire OCT System is intended for use in conjunction with other standard methods for evaluation of the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.