Summary for ARTG Entry:
GE Healthcare Australia Pty Ltd - Nuclear medicine system, SPECT, application program software
ARTG entry for
Medical Device Included Class IIa
GE Healthcare Australia Pty Ltd
PO Box 5079,PARRAMATTA DC, NSW, 2150
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.
GE Medical Systems SCS
283 rue de la Miniere
BP34, Buc Cedex, 78533
1. Nuclear medicine system, SPECT, application program software
Single Device Product
40869 Nuclear medicine system, SPECT, application program software
This software is intended for processing and reading non-cardiac volumetric data, including NM SPECT
and hybrid SPECT-CT, PET-CT, external CT/MR (CT/MR from a separate non-hybrid scan). For follow-up
studies, two studies can be registered and viewed simultaneously, each including its reference data.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:42:54 AEDT
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