# K230209: Sonix Health

- Pathway: 510(k) (Traditional)
- Applicant: Ontact Health Co., Ltd.
- Decided: Oct 20, 2023 after 268 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: 20 generations back to K935595 (1995). 147 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213544: Tomtec-Arena, Tomtec Imaging Systems GmbH (2022) Summary page 4.

## Most influential descendants
- K243684: BrightHeart View Classifier (2025), 1 descendant of its own
- K251456: BrightHeart View Classifier (2025), 0 descendants of its own
- K240645: Sonix Health (2024), 0 descendants of its own

## 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/K230209
Methodology: https://510kreport.com/methodology