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Information system software, application program, radiology - ARTG 474985

Access comprehensive regulatory information for Information system software, application program, radiology in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 474985 and sponsored by Regional Health Care Group Pty Ltd, manufactured by Acist Medical Systems Inc in United States of America. The device registration started on January 03, 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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TGA ARTG Official Data
Class I
ARTG 474985
Class I
Information system software, application program, radiology
ARTG ID: 474985
Good Name: Regional Health Care Group Pty Ltd - Information system software, application program, radiology
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Intended Purpose

NEXO is a data management system intended to track injection data within Radiology. NEXO collects patient and examination data from Radiology Information System (RIS) and shares it with CT Exprรจs Evo and EmpowerCTA+ injectors. NEXO is also able to collect IV contrast and saline doses and procedure data from CT Exprรจs Evo and EmpowerCTA+ injectors in order to store, graphically display and share the data with Hospital Information System (HIS) and Picture Archiving and Communication Systems (PACS).

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
474985
Start Date
January 03, 2025
Effective Date
January 03, 2025
Manufacturer
Country
United States of America
Address
7905 Fuller Road, Eden Prairie, MN, 55344