Device Dossier
Video capsule endoscopy system
Device Dossier for Video capsule endoscopy system (Video capsule endoscopy system, Class IIa, sponsor Medtronic). ARTG record, intended purpose, GMDN…
- GMDN category: Video capsule endoscopy system
Intended purpose
Pillcam Crohn’s capsule is intended for the internal visualisation and examination of the colon, small bowel and gastrointestinal tract. The Crohn’s Pillcam system is comprised Crohn’s capsule, recorder with sensors to receive and store images collected during the procedure, software which processes and transforms image into viewable video to review.