Devices · Perimeter Medical Imaging Ai, Inc.

Claire™ OCT System

Perimeter Medical Imaging Ai, Inc. is listed for Claire™ OCT System (P250008). The FDA list gives March 3, 2026 as the date of the final decision. The lead panel is General and Plastic Surgery, and the database link on the FDA list is the PMA pathway. openFDA describes product code SHH as “Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer”: Intended as an adjunctive tool for intraoperative imaging and detection of cancer in breast tissue during excisional breast surgery (e.g., lumpectomy). openFDA records decision code APPR for this submission. This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250008

Official FDA database record

Date of final decision

March 3, 2026

Company on the FDA list

Perimeter Medical Imaging Ai, Inc.

Lead panel

General and Plastic Surgery

Primary product code

SHH

openFDA device name for the code

Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer

Device class

3

Regulation number

Not returned

openFDA decision description

Not returned

openFDA decision code

APPR

Statement or summary label

Statement