# Clarius AI

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/clarius-ai-qih>
- Manufacturer: [Clarius Mobile Health Corp.](https://devicerts.com/manufacturers/fda-fei-3012747207) (Canada)
- Device class: Class II (US FDA)
- FDA product code: QIH

## Overview

Clarius AI is a highly advanced automated radiological image processing software designed to improve the quality and efficiency of medical imaging procedures. This proprietary technology enables clinicians to analyze complex images with greater speed and accuracy, leading to better patient outcomes and reduced radiation exposure.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K222406 · decision 2023-01-23 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K222406 [FDA 510(k)]
- FDA product code: QIH [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.2050 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Clarius AI, Clarius Mobile Health Corp. deviCERTS medical device catalogue. https://devicerts.com/devices/clarius-ai-qih (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/clarius-ai-qih.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/clarius-ai-qih
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.