Summary for ARTG Entry:
Fujifilm Sonosite Australasia Pty Ltd - Ultrasonic/electromagnetic-guided needle kit
ARTG entry for
Medical Device Included Class IIa
Fujifilm Sonosite Australasia Pty Ltd
PO Box 57,BELROSE WEST, NSW, 2085
ARTG Start Date
Medical Device Class IIa
- 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.
Soma Access Systems LLC
109 Laurens Road
Greenville, South Carolina, 29607
United States Of America
1. Ultrasonic/electromagnetic-guided needle kit
Single Device Product
60443 Ultrasonic/electromagnetic-guided needle kit
The AxoTrack I Sterile Procedure Kit is intended to provide physicians with tools for electromagnetic
tracking instruments with respect to image data.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 10:39:08 AEDT
This is not an ARTG Certificate document.
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