Summary for ARTG Entry:
Philips Electronics Australia Ltd - Workstation, MRI system
ARTG entry for
Medical Device Included Class 1
Philips Electronics Australia Ltd
Locked Bag 30,NORTH RYDE BC, 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.
3545 SW 47th Avenue
Gainesville, FL, 32608
United States Of America
1. Workstation, MRI system
Single Device Product
40940 Workstation, MRI system
Device indicated for use in conjunction with an MR scanner, as an accessory to entertain the patient
during the performance of any MRI procedure. To be used in conjunction with a Magnetic Resonance
Scanner to analyze data acquired using Blood Oxygen Level Dependent (BOLD) contrast techniques,
such analysis that can be interpreted by a trained physician.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:18:34 AEDT
This is not an ARTG Certificate document.
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