Summary for ARTG Entry:
AGFA HealthCare Australia - Picture archiving and communication system, radiology
ARTG entry for
Medical Device Included Class IIa
AGFA HealthCare Australia
PO Box 9149,SCORESBY, VIC, 3179
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.
Agfa HealthCare N.V
Mortsel, , 2640
1. Picture archiving and communication system, radiology
Single Device Product
35719 Picture archiving and communication system, radiology
The IMPAX Agility Solution will provide to qualified healthcare professionals a method to store, display,
distribute medical images; to display, review, enter and edit the associated study information and to create,
and distribute reports.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 08:06:58 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
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