734058fa-9fc1-469e-9a48-c5e7d4a11012UpdatePublished42021-07-022016-09-132021-06-30Not in Commercial Distribution04562122955799PrimaryGS1HITACHIUST-984-5693002605HITACHI, LTD.1ProbefalsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse40771Rectal/vaginal ultrasound imaging transducerAn invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.falseActiveIYOSystem, Imaging, Pulsed Echo, UltrasonicITXTransducer, Ultrasonic, DiagnosticIYNSystem, Imaging, Pulsed Doppler, UltrasonicStorage Environment TemperatureStorage Environment HumidityStorage Environment Atmospheric PressureHandling Environment TemperatureHandling Environment HumidityHandling Environment Atmospheric Pressurefalsefalse