THD Digital Mobile, THD HR Station - Ultrasound system, imaging, general-purpose - ARTG 410521
Access comprehensive regulatory information for THD Digital Mobile, THD HR Station - Ultrasound system, imaging, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 410521 and sponsored by Medical Specialties Australasia Pty Ltd, manufactured by THD SpA in Italy. The device registration started on June 14, 2023.
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Intended for the recording/processing of images and/or videos of the anorectal channel and/or pelvic region (with the assistance of dedicated video camera and/or ultrasound probe). The system (and/or procedure pack) incorporates software that can also be used for the acquisition of the mean pressure signal transmitted by an anorectal manometry unit for viewing and subsequent processing (examination report & report printing). The software also allows for the relevant healthcare professional to follow the clinical history of a patient (e.g. multiple anoscopy exams) and generate/print examination reports. Depending on configuration, the system/procedure pack may be supplied without (i.e. supplied separately) or with ultrasound probe and/or video camera and/or anorectal manometry unit.