Sonix Health
Ontact Health Co., Ltd.Sonix Health is a software product that assists clinicians in analyzing adult echocardiography ultrasound images. It uses artificial intelligence to automatically classify ultrasound views, segment anatomy, and perform semi-automated measurements, helping physicians quantify cardiac function more efficiently. The software generates reports based on B-mode, M-mode, and Doppler ultrasound images and supports manual verification and adjustment of AI results.
Intended Use
Sonix Health is intended for quantifying and reporting echocardiography for use by or on the order of a licensed physician. It accepts DICOM-compliant medical images from ultrasound devices and is indicated for use in adult populations. Ultrasound images include B (2D), M, Pulsed-wave Doppler, and Continuous-wave Doppler modes.
Technology
Sonix Health is installed on customer PC hardware and operates within a local DICOM-compliant network. It uses a two-step AI algorithm: single identification model for view classification, followed by deep learning models for segmentation and measurement of B-mode, M-mode, and Doppler ultrasound images. The software provides automated analysis with manual verification and adjustment options.
Performance
Performance testing included 2,744 clinical images from B-mode, M-mode, and Doppler categories with training and validation datasets from US and South Korean hospitals. Testing showed 98.22% average accuracy in view recognition and 93.98% correlation with expert manual measurements. Software verification complied with IEC 62304 and other standards. No direct clinical testing was conducted for substantial equivalence but validation showed safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/25/2023
8 months - 2
FDA Approval
10/20/2023
Other devices from Ontact Health Co., Ltd.
- Sonix Health2024 • 510K
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