Summary for ARTG Entry:
AGFA HealthCare Australia - Picture archiving and communication system, software
ARTG entry for
Medical Device Included Class 1
AGFA HealthCare Australia
PO Box 9149,SCORESBY, VIC, 3179
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.
2 rue Pierre-Joseph Colin
, Rennes, 35000
1. Picture archiving and communication system, software
Medical device system
41670 Radiology picture archiving and communication system application software
DICOM Izer™ is a device that receives medical images (including mammograms) and data from
various imaging sources. Images and data can be stored, communicated, processed and displayed
within the system or across computer networks at distributed locations.
No Specific Conditions included on Record
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Produced at 09.11.2017 at 11:01:41 AEDT
This is not an ARTG Certificate document.
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