Device Dossier
Endoscopic video image processor
Device Dossier for Endoscopic video image processor (Endoscopic video image processor, Class IIa, sponsor Olympus). ARTG record, intended purpose, GMDN…
- GMDN category: Endoscopic video image processor
Intended purpose
An endoscopy computer-aided detection (CAD) system that is intended to assist physicians in the detection of abnormalities during an endoscopic procedure. It processes the electronic signals received from an endoscopy video system centre and overlays additional information on the observation monitor. It is an adjunctive tool and users should not rely solely on the device for the detection of abnormalities.