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Endoscopic video image interpretive software - ARTG 483068

Access comprehensive regulatory information for Endoscopic video image interpretive software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 483068 and sponsored by Medtronic Australasia Pty Ltd, manufactured by Linkverse S.R.L in Italy. The device registration started on March 19, 2025.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIb
ARTG 483068
Class IIb
Endoscopic video image interpretive software
ARTG ID: 483068
Good Name: Medtronic Australasia Pty Ltd - Endoscopic video image interpretive software
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Intended Purpose

The device is intended to process colonoscopy images containing regions consistent with colorectal lesions like polyps. The device is used by trained clinicians as an adjunct to colonoscopy for the purpose to highlighting regions suspected to have visual characteristic consistent with different types of mucosal abnormalities, colorectal lesions such as polyps and provided an estimation of the possible polyps histology.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
483068
Start Date
March 19, 2025
Effective Date
March 19, 2025
Manufacturer
Country
Italy
Address
Via Ostiense n 131/L, Roma, 00154