Pure Global

Radiology DICOM image processing application software

Access comprehensive regulatory information for Radiology DICOM image processing application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Im is sponsored by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes, manufactured by Depuy Orthopaedics Inc in United States of America. The device registration started on December 12, 2019.

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 Im
Class Im
Radiology DICOM image processing application software
Australia TGA ARTG Registered Device
Good Name: Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Radiology DICOM image processing application software
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Intended Purpose

This is an image processing software that is intended to assist in preoperative planning, intraoperative analysis, and postoperative review of orthopaedic procedures.

Device Classification
Risk Class
Class Im
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 12, 2019
Effective Date
December 12, 2019
Manufacturer
Country
United States of America
Address
700 Orthopaedic Drive, Warsaw, IN, 46582