Handheld Ultrasound Scanner
IMGFAX CO., LTD.This is a portable, handheld ultrasound imaging system that connects wirelessly to a mobile device, enabling doctors and healthcare professionals to perform real-time, high-resolution ultrasound scans across a wide range of body areas. It is designed to support convenience, versatility, and rapid bedside imaging to assist patient care.
Intended Use
A software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body.
Technology
A portable, software-controlled handheld ultrasound system with wireless transducers using Wi-Fi to connect to mobile devices. The system is controlled via a dedicated app, supports multiple imaging modes (B mode, M mode, Doppler modes), and enables real-time image export and display on iOS, Android, or Windows devices.
Performance
Non-clinical performance testing included electrical safety, electromagnetic compatibility (EMC), software verification and validation testing (moderate level of concern), biocompatibility, and usability testing. All tests demonstrated compliance with relevant safety and performance standards. No clinical test data was used.
Predicate Devices
No predicate devices specified
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