Summary for ARTG Entry:
GE Healthcare Australia Pty Ltd - X-ray system, diagnostic, general-purpose, portable, digital
ARTG entry for
Medical Device Included Class IIb
GE Healthcare Australia Pty Ltd
PO Box 5079,PARRAMATTA DC, NSW, 2150
ARTG Start Date
Medical Device Class IIb
- 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.
Konica Minolta Inc
1 Sakura-machi Hino-shi
TOKYO, , 1918511
1. X-ray system, diagnostic, general-purpose, portable, digital
Single Device Product
37643 X-ray system, diagnostic, general-purpose, portable, digital
This device is intended for use in a variety of routine planar x-ray imaging applications. It uses digital
techniques for image capture, display and manipulation. This system is indicated for use in generating
radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in
general-purpose diagnostic procedures.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 05:28:38 AEDT
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