Summary for ARTG Entry:
Smith & Nephew Pty Ltd - Image segmentation application software
ARTG entry for
Medical Device Included Class 1
Smith & Nephew Pty Ltd
PO Box 393, North Ryde, NSW, 1670
ARTG Start Date
Medical Device Class 1
- 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.
Smith & Nephew Inc Endoscopy Division
150 Minuteman Road
Andover, Massachusetts, 01810
United States Of America
1. Image segmentation application software
Single Device Product
47502 Image segmentation application software
The DYONICS PLAN software is 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 to an output file. It is
also intended as pre-operative or post-operative software for simulating/evaluating hip preservation
surgical treatment options and historical case review, respectively.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:28:29 AEDT
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