# K253593: Clarius Ejection Fraction AI

- Pathway: 510(k) (Traditional)
- Applicant: Clarius Mobile Health Corp.
- Decided: Mar 2, 2026 after 105 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K935595 (1995). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210747: Caption Interpretation Automated Ejection Fraction Software, Caption Health (2022) Summary page 5.

## Indications for use
Clarius Ejection Fraction AI is intended for semi-automatic non-invasive measurement of the left ventricular ejection fraction on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., phased array and curvilinear scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius Ejection Fraction Al is intended for use in adult patients only.

Source page: https://510kreport.com/device/K253593
Methodology: https://510kreport.com/methodology