Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Picture archiving and communication system, software
ARTG entry for
Medical Device Included Class IIa
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
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.
555 Twelfth Street Suite 2060
Oakland, CA, 94607
United States Of America
1. Picture archiving and communication system, software
Single Device Product
41670 Radiology picture archiving and communication system application software
The product is a software device intended to be used by medical professionals for storage, review, query/
retrieve, analysis, and post processing of DICOM medical images that are generated by
echocardiography, radiology, and other modalities. The device can be used as a stand-alone product or in
a networked system. It is not intended for use with mammograms.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:50:29 AEDT
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