PMA P250008

Device: Claire™ OCT System
Applicant: Perimeter Medical Imaging Ai, Inc.
PMA number: P250008
Supplement: S001
Product code: SHH
Decision date: 2026-08-10
Classification: General, Plastic Surgery
Generic name: OCT imaging system with AI/ML software for adjunctive detection of breast cancer
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.

Current openFDA PMA Record#

Device: Claire™ OCT System
Applicant: Perimeter Medical Imaging Ai, Inc.
PMA number: P250008
Supplement: S001
Product code: SHH
Generic name: OCT imaging system with AI/ML software for adjunctive detection of breast cancer
Decision date: 2026-08-10
Decision code: APPR
Date received: 2026-03-13
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
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.