# K240645: Sonix Health

- Pathway: 510(k) (Traditional)
- Applicant: Ontact Health Co., Ltd.
- Decided: Nov 27, 2024 after 265 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: 21 generations back to K935595 (1995). 148 ancestors in all.
No later device cites it as a predicate yet.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230209: Sonix Health, Ontact Health Co., Ltd. (2023) Summary page 5.

## Indications for use
Sonix Health is intended for quantifying and reporting echocardiography for use by or on the order of a licensed physician. Sonix Health accepts DICOM-compliant medical images acquired from ultrasound imaging devices. Sonix Health is indicated for use in adult populations. Ultrasound images are acquired via the B (2D), M, Pulsed-wave Doppler, and Continuous-wave Doppler modes.

Source page: https://510kreport.com/device/K240645
Methodology: https://510kreport.com/methodology