Clarius Ultrasound Scanner system - General ultrasound imaging system, battery-powered

Intended purpose

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic1 , fetal, abdominal, intraoperative (non neurological), pediatric, small organ, cephalic (adult), trans-rectal, transvaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body. The system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals. Clarius MSK AI is intended to semi-automatically place calipers for non-invasive measurements of musculoskeletal structures (e.g., Achilles’ tendon, plantar fascia, patellar tendon) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., L7 HD3 and L15 HD3). The user shall be a healthcare professional trained and qualified in MSK (musculoskeletal) ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius Bladder AI is intended for semi-automatic non-invasive measurements of bladder volume on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear and phased array scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius Bladder AI is indicated for use in adult patients only. Clarius OB AI is intended to assist in measurements of fetal biometric parameters (i.e., head circumference, abdominal circumference, femur length, bi-parietal diameter, crown rump length) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear scanner). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius OB AI is indicated for use in adult patients only. Clarius Prostate AI is intended for semi-automatic measurements of prostate volume on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear and endo-cavitary scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius Prostate AI is intended for use in adult male patients only. Clarius Median Nerve AI is intended for segmentation and semi-automatic non-invasive measurements of the median nerve cross-sectional area on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., linear array scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius Median Nerve AI is intended for use in adult patients only.