Device Dossier
Endoscopic video image interpretive software
Device Dossier for Endoscopic video image interpretive software (Endoscopic video image interpretive software, Class IIa, sponsor Fujifilm). ARTG record,…
- GMDN category: Endoscopic video image interpretive software
Intended purpose
This software detects and characterizes an area suspected to be a colonic polyp in an endoscopic video image outputted from an endoscopic video processor. The software superimposes the result of Detection Mode or Characterization Mode onto the endoscopic video image and displays on the monitor in real-time. This software is intended to be used to support diagnosis during colonoscopy under the supervision of medical professionals.