MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
ImpediMed LimitedMySOZO Software version 6.0.1.2 is a cloud-based software used with SOZO or SOZO Pro devices to noninvasively measure body fluid and composition via bioimpedance spectroscopy. It helps clinicians monitor fluid management in heart failure patients and assess extracellular fluid differences for lymphedema risk. It calculates body composition parameters including fat mass, total body water, and skeletal muscle mass, providing useful clinical data for patient management.
Intended Use
Intended for adult patients with heart failure for noninvasive fluid monitoring, and for adult patients at risk of lymphedema by measuring extracellular fluid differences via L-Dex ratio.
Technology
Cloud-based software facilitating bioimpedance spectroscopy measurements via SOZO or SOZO Pro devices. Measures electrical impedance parameters across multiple frequencies (3kHz to 1000kHz) to estimate body composition and fluid status. Uses Bluetooth paired tablet application and transmits data to cloud database for analysis and display.
Performance
Verification and validation testing were performed for software updates including user interface alignment, Bluetooth connectivity improvements, and L-Dex assessment module update. Algorithm verification confirms safe and effective performance matching predicate device.
Predicate Devices
No predicate devices specified
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