510(k) K253593 ยท QIH Automated Radiological Image Processing Software
Clarius Ejection Fraction AI
| Applicant | Clarius Mobile Health Corp., Vancouver, CA |
| Decision | Substantially Equivalent, Mar 2, 2026 |
| Received | Nov 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253593
No recall in the FDA data names this 510(k).
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