Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Radiology picture archiving and communication system
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
- 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.
Hyland Software Canada ULC
111 Peter Street Suite 540
Toronto, Ontario, M5V 2H1
1 . Radiology picture archiving and communication system application software
Single Device Product
41670 Radiology picture archiving and communication system application software
The NilRead software application provides desktop and portable access to multi-modality softcopy medical images, reports and
other patient-related information for conducting diagnostic review, planning, and reporting through the interactive display and
manipulation of medical data, including mammography. NilRead also allows users to collaborate by sharing application sessions.
Mammographic images should only be viewed with a monitor approved by the FDA for viewing mammographic images, or monitors
with similar specifications. On portable (mobile) platforms, this device is not intended to replace full workstations and should be
used only when there is no access to a workstation. It is the user's responsibility to ensure the software is installed on appropriate
hardware and to verify display image quality is suitable for the clinical application. Mobile use is not intended for diagnostic review
of Mammography and DBT.
NilRead is intended for use by physicians trained in reviewing and interpreting medical images.
No Specific Conditions included on Record
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Produced at 22.07.2020 at 08:29:48 AEST
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