CaseManager DX

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CaseManager DX — IVDR Class A IVDR by 3DHISTECH Kft.

Market distribution

Primary placement in Hungary; available across 32 countries total.

Country	On market since	Until
HungaryPrimary placement		Still on market
Austria		Still on market
Belgium		Still on market
Bulgaria		Still on market
Cyprus		Still on market
Czechia		Still on market
Germany		Still on market
Denmark		Still on market
Estonia		Still on market
EL		Still on market
Spain		Still on market
Finland		Still on market
France		Still on market
Croatia		Still on market
Ireland		Still on market
Iceland		Still on market
Italy		Still on market
Liechtenstein		Still on market
Lithuania		Still on market
Luxembourg		Still on market
Latvia		Still on market
Malta		Still on market
Netherlands		Still on market
Norway		Still on market
Poland		Still on market
Portugal		Still on market
Romania		Still on market
Sweden		Still on market
Slovenia		Still on market
Slovakia		Still on market
Türkiye		Still on market
XI		Still on market

Device details

Quantity: 1
Additional product description: The CaseManager™ DX Software application, developed by 3DHISTECH, is an in vitro diagnostic (IVD) medical device designed to exchange, identify, store and manage electronic health records, to receive, identify and manage digital images of surgical pathology and cytology slides – digital sections primarily obtained from formalin-fixed paraffin-embedded (FFPE) tissue specimens and cytology samples (vaginal smears. It is intended for use by healthcare professionals (e.g.: qualified pathologists) in clinical laboratory and hospital settings on all individuals without population restrictions. The software provides tools for pathologists to manage the cases, view, interpret and analyze the linked electronic health records and the medical images in the ClinicalViewer™ module or in the WebViewer, and to write reports, while ensuring that only the relevant electronic health records and digital images can be accessed and utilized for diagnostic purposes. CaseManager™ DX Software and the ClinicalViewer™ are integrated with the Diagnostic Applications™ software which is a modular image analysis platform intended to assist in the quantitative evaluation of digital histopathology slides. The software facilitates region-based image analysis through a common infrastructure that manages sample metadata, provides access to image data, supports interactive review, and stores analysis results within the case record. The platform includes a variety of image analysis (sub)modules that are clearly categorized and labelled in the user interface and documentation according to their regulatory status and intended use. The software is intended to support, not replace, the professional judgment of a qualified pathologist and should always be used in conjunction with other clinical and laboratory information. The software platform does not generate standalone diagnostic conclusions; its outputs must always be interpreted by qualified professionals in the clinical context.
Additional information URL: https://www.3dhistech.com/
Clinical sizes: No clinical sizes registered for this device.

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