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12 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Clarius Mobile Health Corp.
Authorized purpose: Semi-automated measurement of left ventricular ejection fraction during cardiac ultrasound.
Clarius Mobile Health Corp.
Authorized purpose: Segmentation and semi-automatic, non-invasive median-nerve cross-sectional-area measurement during ultrasound acquisition.
Clarius Mobile Health Corp.
Authorized purpose: Clarius Prostate AI provides semi-automatic measurements of prostate volume from ultrasound data acquired by the Clarius Ultrasound Scanner.
Clarius Mobile Health Corp.
Authorized purpose: Clarius OB AI assists a trained and qualified healthcare professional with measurements of fetal biometric parameters, including head circumference, abdominal circumference, femur length, biparietal diameter, and crown-rump length, on data acquired by the Clarius curvilinear ultrasound scanner.
Clarius Mobile Health Corp.
Authorized purpose: Provide semi-automatic, non-invasive bladder-volume measurements from ultrasound data acquired by the Clarius Ultrasound Scanner using curvilinear or phased-array scanners; a healthcare professional trained and qualified in ultrasound retains responsibility for the measurements, and the device is indicated for adults only.
Clarius Mobile Health Corp.
Authorized purpose: The Clarius Ultrasound Scanner is a software-based, transportable ultrasound imaging system for diagnostic ultrasound imaging and fluid-flow analysis across the labeled ophthalmic, fetal, abdominal, intraoperative, pediatric, small-organ, cephalic, transrectal, transvaginal, musculoskeletal, urologic, gynecologic, cardiac, peripheral-vessel, carotid, and needle-guidance applications.
Clarius Mobile Health Corp.
Authorized purpose: Semi-automatic caliper placement for non-invasive musculoskeletal tendon-thickness measurements on ultrasound data.
Clarius Mobile Health Corp.
Authorized purpose: Clarius Ultrasound Scanner is a general-purpose diagnostic ultrasound system for trained healthcare professionals across the labeled fetal, abdominal, pelvic, small-organ, cephalic, cardiac, vascular, musculoskeletal, and urologic applications.
Clarius Mobile Health Corp.
Authorized 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 labeled ophthalmic, fetal, abdominal, intraoperative, pediatric, small-organ, cephalic, transrectal, transvaginal, musculoskeletal, urology, gynecology, cardiac, peripheral-vessel, carotid, and needle-guidance applications. It is transportable and intended for environments where healthcare is provided by trained professionals.
Clarius Mobile Health Corp.
Authorized 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 ophthalmic, fetal, abdominal, intraoperative, pediatric, small-organ, adult-cephalic, transrectal, transvaginal, musculoskeletal, urology, gynecology, cardiac, peripheral-vessel, carotid, and needle-guidance applications. It is transportable and intended for environments where healthcare is provided by trained healthcare professionals.
Clarius Mobile Health Corp.
Authorized purpose: The Clarius Ultrasound Scanner is a software-based diagnostic ultrasound imaging system for trained healthcare professionals across labeled abdominal, thoracic, musculoskeletal, breast, thyroid, testicular, pediatric, neonatal, cardiac, vascular, transrectal, transvaginal, and procedural workflows.
Clarius Mobile Health Corp.
Authorized purpose: The Clarius Ultrasound System is a software-based ultrasound imaging system and accessories for point-of-care imaging of medical conditions, including emergency triage for trauma, needle guidance, and targeted fetal, abdominal, small-organ, musculoskeletal, urology, gynecology, adult and pediatric cardiac, peripheral-vessel, pediatric, and carotid applications. It is intended for trained medical professionals in professional healthcare facilities and is not intended for emergency medical service, ambulance, or aircraft use.