Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Orthopaedic implantation application software
ARTG entry for
Medical Device Included Class Im
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
ARTG Start Date
Medical Device Class Im
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Leuven, , 3001
1. Orthopaedic implantation application software
Single Device Product
46470 Orthopaedic implantation application software
Intended for use as a software interface and image segmentation system for the transfer of imaging
information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner.
The device is also used as pre-operative software for simulating /evaluating implant placement and
surgical treatment options.
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 02.12.2017 at 04:59:56 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information