Summary for ARTG Entry:
Epic-X Pty Ltd - Picture archiving and communication system, software
ARTG entry for
Medical Device Included Class IIa
Epic-X Pty Ltd
9 / 185 Briens Road,NORTHMEAD, NSW, 2152
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.
Olea Medical SA
93 Avenue Des Sorbiers
La Ciotat, , 13600
1. Picture archiving and communication system, software
Single Device Product
41670 Radiology picture archiving and communication system application software
Olea Sphere is an image processing software package to be used by trained professionals including but
not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf"
workstation and can be used to perform image viewing, processing and analysis of medical images. Data
and images are acquired through DICOM compliant imaging devices and modalities.
Olea Sphere provides both viewing and analysis capabilities of functional and dynamic imaging datasets
acquired with MRI or other relevant modalities; including a Diffusion-Weighted MRI (DWI) / Fiber Tracking
Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT).
No Specific Conditions included on Record
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Produced at 02.12.2017 at 05:29:10 AEDT
This is not an ARTG Certificate document.
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