Case Manager DX

Primary DI

05999571470150

Basic UDI-DI Code

599957147155SE

Reference

DX-CASEM-0

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

3DHISTECH Kft.

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) – produced by 3DHISTECH's PANNORAMIC® Diagnostic Scanner Software with one of the four Whole Slide Imaging (WSI) scanners (PANNORAMIC® 1000 DX Digital Scanner; PANNORAMIC® 480 DX Digital Scanner; PANNORAMIC® 250 Flash III DX Digital Scanner; PANNORAMIC® Flash DESK DX Digital Scanner) – and store those in the SlideStorageDX™ module. It links electronic health records and medical images to cases for pathologists in a centralized database. 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, and to write reports, while ensuring that only the relevant electronic health records and digital images can be accessed and utilized for diagnostic purposes. Pathologists using the CaseManager™ DX Software and its modules are responsible for following appropriate procedures and safeguards to ensure the validity of image interpretation. While the software assists in the diagnostic process in conjunction with other clinical and laboratory information, it should not be used as a substitution for the professional judgment of a qualified pathologist.

Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).