General and Plastic Surgery · PMA · 2026
Claire OCT System
Perimeter Medical Imaging Ai, Inc.. Approved by FDA on 3 March 2026 under submission P250008, product code SHH (oct imaging system with ai/ml software for adjunctive detection of breast cancer). What FDA's record says, in FDA's words.
Device record · P250008
- Device. Claire OCT SystemDEVICE
- Company. Perimeter Medical Imaging Ai, Inc.COMPANY
- Decision. 3 March 2026, PMA, apprDECISION
- Panel. General and Plastic SurgeryPANEL
- Product code. SHH, Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast CancerCODE
- Source. FDA database entry · decision document (27 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA approved it for
The Indications for Use statement, verbatim, from the decision document.
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. Claire 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.
The product code's definition, from FDA's classification record. Intended as an adjunctive tool for intraoperative imaging and detection of cancer in breast tissue during excisional breast surgery (e.g., lumpectomy).
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SHH. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SHH, in General and Plastic Surgery, from Perimeter Medical Imaging Ai, Inc., or approved in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.