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X-ray image interpretive software - ARTG 470185

Access comprehensive regulatory information for X-ray image interpretive software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 470185 and sponsored by Freyr Australia Pty Ltd, manufactured by AZmed in France. The device registration started on November 25, 2024.

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 IIa
ARTG 470185
Class IIa
X-ray image interpretive software
ARTG ID: 470185
Good Name: Freyr Australia Pty Ltd - X-ray image interpretive software
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Intended Purpose

Rayvolve helps detect fractures on osteoarticular X-rays of the following organs: hand, wrist, forearm, elbow, arm, shoulder, foot, ankle, leg,knee, femur. Rayvolve can analyze X-rays of adult and pediatric patients. The radiographs analyzed are Computed Radiography (CR), Radio Fluoroscopy (RF) et Digital Radiography (DX). Rayvolve intended users are: Radiologist Emergency physicians

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
470185
Start Date
November 25, 2024
Effective Date
November 25, 2024
Manufacturer
Name
AZmed
Country
France
Address
20 Rue Des Petits Champs, Paris, 75002