4327acb9-1a17-4173-a08c-20e461e3446fUpdatePublished52023-01-112016-09-28In Commercial Distribution06945121400206PrimaryGS106945121414586PackageGS1069451214002062In Commercial DistributionLinear probeD7L40L-REC544914187CHISON Medical Technologies Co., Ltd.1falsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK15308500040771Rectal/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.falseActiveITXTransducer, Ultrasonic, Diagnosticfalsefalse