Information system software, application program, patient record

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Nico.lab International Limited

classe:

Class I

Fabriqué par:

NICo-Lab BV Paasheuvelweg 25, Amsterdam, 1105BP Netherlands

Domaine thérapeutique:

44106 - Information system software, application program, patient record

indications thérapeutiques:

StrokeViewer is a service image software processing application that analyses stroke imaging data. From the analysis a report is compiled containing visualization of stroke-relevant imaging properties that can assist a physician in diagnosis of stroke. StrokeViewer is used by a physician, or a person working under the supervision of a physician, at radiological or emergency departments. StrokeViewer is intended to be used in assisting the diagnosis of all patients with (acute) neurological deficit due to (suspected) stroke. StrokeViewer is not intended to be used in diagnosis decision support; the direct diagnosis is decided upon by the physician. StrokeViewer is a fully automated application executed in a remote cloud based environment, and operates in a complete secure environment. Received DICOM images are automatically analysed, and an analysis report is transferred back. Furthermore, a DICOM webviewer is enabled for the user with credentials, to view the analysed data.

Statut de autorisation:

A

Date de l'autorisation:

2019-01-07