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FDA-cleared K230209

Sonix Health

Ontact Health Co., Ltd.

Authorized purpose: 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