Author: Souheil Adra, MD
Healcerion Co., Ltd received FDA approval for SONON Ultrasound Imaging System, Model: 300C on September 10, 2015.
The SONON 300C device is a battery-operated, hand-held, wireless ultrasound system for use in general abdominal, obstetric/fetal, and gynecologic diagnostic imaging. It wirelessly transmits ultrasound images to an off-the-shelf commercial device running a mobile app utilizing iOS or Android operating systems. The app will allow the images to be displayed onto the screen of the device with a size ranging from 4-10 inches depending on whether a paired mobile phone or a tablet is used. The ultrasound probe possesses a convex array and it emits 3.5MHz pulsed-echo, as well as B mode.
The device met non-clinical performance criteria for electrical safety, acoustic output levels, clinical measurement range, display performance, usability, failure mode and risk analysis, biocompatibility, and cybersecurity. No clinical tests or animal studies were needed due to its similarity to predicate devices.
The FDA has determined this device to be substantially equivalent to predicate devices: MobiUS Ultrasound Imaging System (Mobisante, Inc.), and Penrith Elettra Diagnostic Ultrasound System (Penrith Corp.).
The device is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including general abdominal, fetal/obstetrics, and gynecology.
It is intended for use by healthcare professionals in a hospital, clinic and medical office settings.