310 Edward St, Brisbane City QLD 4000
EU authorised representative name and address:
EC REP Advena Ltd. Tower Business Centre, 2nd Flr., Tower Street, Swatar, BKR 4013 Malta.
Date of release:
24 November 2020
UPI [Unique product Identifer] as a text:
Medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points and associated clinical data including pathology results, patient history and patient symptoms.
Supports anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
Supports datasets of measured or calculated values such as measured blood markers. These can be viewed in a number of output formats including tabulated and as graphs.
Supports qualitative information of patients such as family history. This can be viewed as text, and summarised information.
Enables visualization of information that would otherwise have to be visually compared disjointedly.
Provides analytical tools to help the user assess and document changes in patient data and morphological activity at screening, diagnostic and therapy follow-up examinations.
Designed to support the oncological workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions.
Designed to support the screening workflow by helping the user assess patient risk through their inclusion or exclusion in certain cohorts based on their data.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images.
This product is intended to be used to support qualified radiologist, urologists, oncologists, or other licensed professional healthcare practitioners for clinical decision-making.3