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Claire OCT System

by Perimeter Medical Imaging Ai, Inc. Canada PMA

PMA P250008

Product code SHH

Overview

The Claire OCT System is a Class III optical coherence tomography (OCT) imaging device with integrated artificial intelligence/ machine learning software. It provides real-time, volumetric cross-sectional imaging to visualize tissue depth and is designed as an adjunctive tool for identifying suspicious focal areas in breast cancer evaluation during surgical procedures.

This device is intended for use in conjunction with standard margin assessment methods during lumpectomy surgeries in patients with biopsy-confirmed breast cancer. Supplied sterile and single-use, it operates in the operating room setting and requires FDA_PMA authorization (PMA Number: P250008). The system is classified under product code SHH and is manufactured by Perimeter Medical Imaging Ai, Inc.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP250008 Date3 Mar 2026ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA PMA Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

PMA · synced 22 Oct 2026

Generic Name
OCT imaging system with AI/ML software for adjunctive detection of breast cancer
PMA Number
FDA Product Code
SHH
Device Class
Class III
Advisory Committee
General, Plastic Surgery
FDA Decision
APPR Approved

Other devices from Perimeter Medical Imaging Ai, Inc.

Questions

  • What specific surgical setting is the Claire™ OCT System designed to assist with during breast cancer procedures?

    The Claire™ OCT System is intended for use during lumpectomy surgeries as an adjunctive tool to help visualize tissue margins in real-time. It provides volumetric cross-sectional imaging to identify suspicious focal areas, which can aid surgeons in evaluating excised breast tissue from patients with biopsy-confirmed breast cancer.

  • Is the Claire™ OCT System reusable or single-use, and how does this affect its use in the operating room?

    The Claire™ OCT System is supplied sterile and designed for single-use only. This ensures hygiene and reduces the risk of cross-contamination in the operating room, making it ideal for surgical settings where sterility is critical.

  • How does the AI/ML software integrated into the Claire™ OCT System enhance the imaging process?

    The AI/ML software in the Claire™ OCT System analyzes real-time volumetric cross-sectional images to identify and mark focal areas that may be suspicious for breast cancer. It serves as a computer-aided detection tool, assisting physicians in interpreting the images alongside standard margin assessment methods during surgery.

  • What regulatory pathway was followed for the Claire™ OCT System, and what does this mean for its use?

    The Claire™ OCT System underwent the FDA Premarket Approval (PMA) process, which is required for Class III medical devices. This means it has been thoroughly evaluated for safety and effectiveness as an adjunctive imaging tool for breast cancer margin assessment during lumpectomy procedures, ensuring it meets stringent regulatory standards before clinical use.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA PMA P250008 23 fields · synced 22 Oct 2026