Orthopaedic implantation application software
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
01-12-2017
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Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class Im
Manufactured by:
Materialise NV Technologielaan 15, Leuven, 3001 Belgium
Therapeutic area:
46470 - Orthopaedic implantation application software
Therapeutic indications:
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.
Authorization status:
A
Authorization date:
2013-11-08
