Ontact Health Co., Ltd radiology AI products

FDA-cleared K240645

Sonix Health

Ontact Health Co., Ltd

Assist licensed physicians with quantifying and reporting adult echocardiography from DICOM ultrasound images.

Modality: Ultrasound
Anatomy: Heart, cardiac chambers, and echocardiographic structures.
Decision: 2024-11-27

FDA-cleared K230209

Sonix Health

Ontact Health Co., Ltd.

Sonix Health quantifies and reports adult echocardiography by or on the order of a licensed physician using B-mode, M-mode, pulsed-wave Doppler, and continuous-wave Doppler images.

Modality: Ultrasound
Anatomy: Heart; adult cardiac structures and function
Decision: 2023-10-20

Cardiac imaging Quantification and segmentation Ultrasound workflow