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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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
Supplement NumberS001
Date Received03/13/2026
Decision Date08/10/2026
Product Code SHH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at RBC Development, LLC (dba Vantage MedTech / RBC Medical Innovations), located at 17100 W 118th Terrace, Olathe, KS 66061, performing cart assembly, consumable (Specimen Immobilizer) assembly, receiving inspection, and tech services and laboratory functions at this facility.
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