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

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/SHH

## Overview

- **Product Code:** SHH
- **Device Name:** Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

Intended as an adjunctive tool for intraoperative imaging and detection of cancer in breast tissue during excisional breast surgery (e.g., lumpectomy).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P250008](/device/P250008.md) | Claire™ OCT System | Perimeter Medical Imaging Ai, Inc. | Mar 3, 2026 | APPR |

## Top Applicants

- Perimeter Medical Imaging Ai, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/productcode/SHH](https://fda.innolitics.com/productcode/SHH)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com