BEUDAMED
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    ITOS standalone

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Voigtmann GmbH·1 device

    BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·February 19, 2014

    iTD GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer

    7333DE410190313

    Certificate
    MDD Annex II (excluding section 4)·VISUS Health IT GmbH·DNV MEDCERT GmbH·1 Basic UDI-DI

    StatConsult IT-Service GmbH

    System producer
    🇩🇪 Germany

    MedNet EC-REP GmbH

    Authorized representative
    🇩🇪 Germany·464 Manufacturers·5263 Devices