Device Dossier

Endoscopic video image interpretive software

Device Dossier for Endoscopic video image interpretive software (Endoscopic video image interpretive software, Class IIb, sponsor Fujifilm). ARTG record,…

Intended purpose

This device is intended to support the observer in interpreting and diagnosing the presence of a lesion by extracting the area that may be oesophageal squamous cell carcinoma or gastric neoplastic lesion in the endoscopic image of the upper gastrointestinal tract and displaying it to the observer of the image to draw the observer's attention to the possible lesion site. The purpose of this product is to "assist the observer in diagnosing the presence of a lesion" and is not intended to make a diagnosis of the presence of a lesion based solely on the detection results of this equipment.

TGA Public Summary