Device Dossier

THD Digital Mobile, THD HR Station - Ultrasound system, imaging, general-purpose

Device Dossier for THD Digital Mobile, THD HR Station - Ultrasound system, imaging, general-purpose (Ultrasound system, imaging, general-purpose, Class…

Intended purpose

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.

TGA Public Summary