Device typeHand-held ultrasound imaging system, body-surface: A battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.
FDA categorySystem, Imaging, Pulsed Doppler, Ultrasonic, System, Imaging, Pulsed Echo, Ultrasonic, Transducer, Ultrasonic, Diagnostic
Device ID07540205000045
Catalog number80-02-00005; 50-02-00005
AvailabilityPrescription
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information