BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Country: Germany ×

    EKU Elektronik GmbH

    Manufacturer
    🇩🇪 Germany

    MK1 Dental-Attachment GmbH

    Manufacturer
    🇩🇪 Germany

    MKI DENTAL PRODUKT GMBH

    FDA registration
    MKI DENTAL PRODUKT GMBH·1 product·🇩🇪 Germany

    EKU Elektronik GmbH

    Importer
    🇩🇪 Germany

    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

    Karl Meng/MKT MED

    Authorized representative
    🇩🇪 Germany

    G2 051317 0005

    Certificate
    MDD Annex V·MK-dent GmbH·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

    Everbiz GmbH

    Authorized representative
    🇩🇪 Germany·44 Manufacturers·110 Devices