Uscan
EchoNous, Inc.The Uscan by EchoNous, Inc. is a handheld diagnostic ultrasound system designed for non-invasive imaging of the human body, including abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging. It also features automated bladder volume measurement, assisting clinicians in quickly and accurately assessing patients without invasive procedures.
Intended Use
The Uscan is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, Small Organ, and Peripheral Vessel. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging. The Uscan can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.
Technology
The Uscan is a handheld diagnostic ultrasound system with an on-screen display running ultrasound software on an off-the-shelf Android tablet. It acquires ultrasound echo data and displays it in B-mode. It supports automated bladder volume measurements and wireless networking.
Performance
The Uscan was designed and evaluated according to FDA recognized standards including IEC 60601 series and ISO standards for medical devices. Bench testing demonstrated the imaging performance and measurement accuracy to be substantially equivalent to predicate devices. Verification and validation reports confirm safety and effectiveness for intended use.
Predicate Devices
No predicate devices specified
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