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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceClaire™ OCT System
Generic NameOCT imaging system with AI/ML software for adjunctive detection of breast cancer
ApplicantPerimeter Medical Imaging Ai, Inc.
555 Richmond St. W
Suite 511
Toronto M5V 3B1
PMA NumberP250008
Date Received03/13/2025
Decision Date03/03/2026
Product Code SHH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT05113927
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedYes
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
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