Souheil Adra, MD
Healcerion Co., Ltd received FDA approval for SONON Ultrasound Imaging System, Model 300L on 10/12/2017.
The SONON 300L is a battery-operated, hand-held wireless ultrasound system. Clinical applications for this device include imaging for musculoskeletal, vascular, breast, thyroid, thoracic/pleural motion and fluid detection imaging.
This device wirelessly transmits ultrasound images to an off-the-shelf commercial device running an 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 whether a mobile phone or a tablet is used. The probe possesses a linear array and it emits 5MHz, 7.5MHz, and 10MHz pulsed-echo and Doppler ultrasound waves, as well as B mode and color scan
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: SONON 300C and Clarius Ultrasound System.
Indications:
Intended for use by healthcare professionals in a hospital, clinic, and medical office settings.
Intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid), and thoracic/pleural motion and fluid detection imaging.
Contraindications:
None listed