Identifiers
- 510(k) Number
- K222406 FDA 510(k)
- FDA Product Code
- QIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222406 | Class II | Active |
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Manufacturer
- Manufacturer
- Clarius Mobile Health Corp.
Sources (1)
- FDA 510(k) K222406 24 fields · synced Jun 26, 2026