BEUDAMED
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    Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·November 11, 2015

    Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.

    FDA Enforcement
    Class I ·Terminated·Brainlab AG·January 27, 2016

    NVT GmbH

    Authorized representative
    🇩🇪 Germany·3 Manufacturers·185 Devices

    Centrifuge 5418R

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Eppendorf SE·1 device

    Kaneka Medical Europe N.V. German Branch

    Importer
    🇩🇪 Germany