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510(k) Data Aggregation
K Number
K230209Device Name
Sonix Health
Manufacturer
Ontact Health Co., Ltd.
Date Cleared
2023-10-20
(268 days)
Product Code
QIH, LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Ontact Health Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
Sonix Health comes with the following functions:
- Checking ultrasound multiframe DICOM
- Echocardiography multiframe DICOM classification and automatic measurement.
- Verification of the results and making adjustments manually.
- Providing the report for analysis
Sonix Health will be offered as SW only, to be installed directly on customer PC hardware. Sonix Health is DICOM compliant and is used within a local network.
Sonix Health utilizes a two-step algorithm. A single identification model identifies a view in the first step. The second step performs the deep learning according to the view. The deep learning algorithms for the second step are categorized as B-mode, and Doppler algorithms. The main algorithm of Sonix Health is to identify the view and segment the anatomy in the image.
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