Device Dossier

Video capsule endoscopy system

Device Dossier for Video capsule endoscopy system (Video capsule endoscopy system, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN…

Intended purpose

The Capsule Endoscopy System is applicable to gastrointestinal tract diseases examination, which mainly consists of three parts: capsule endoscope, image recorder, and image workstation. After being swallowed by a patient, the capsule will move forward along the gastrointestinal tract, take snap shootings, and transmit the photos wirelessly in real time to the recorder carried by the patient. Then physicians can download the photo data to the image workstation, analyze them and give the diagnosis report.

TGA Public Summary