# QNK · Optoacoustic Imaging System

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/RA-misc/QNK

## Overview

- **Product Code:** QNK
- **Device Name:** Optoacoustic Imaging System
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P200003](https://fda.innolitics.com/submissions/RA/RA-misc/QNK/P200003.md) | Imagio Breast Imaging System | Seno Medical Instruments, Inc. | Jan 11, 2021 | APPR |

## Top Applicants

- Seno Medical Instruments, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/RA/RA-misc/QNK](https://fda.innolitics.com/submissions/RA/RA-misc/QNK)

**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