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510(k) Data Aggregation

    K Number
    K110644
    Device Name
    PRAEZIS PLUS
    Date Cleared
    2012-05-24

    (444 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    TATRAMED SPOL. S.R.O.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Praezis Plus system is computer software intended to be used in planning intracranial stereotactic surgeries such as biopsies and treatment of lesions. The intended user of Praezis Plus is a medical doctor - neurosurgeon.
    Device Description
    Praezis Plus is a software tool intended to help the surgeon plan stereotactic treatments. It enables the user to select optimally fitting stereotactic trajectory positions by digitizing the entry (trephination) and target points of the trajectory. If both points define a trajectory which can be set on the operating device, the corresponding device settings are calculated and displayed in the trajectory window. Any trajectory can be defined and displayed in CT and/or MRI slices or reconstructions or angiographic images if they are available. Trajectories are always stored in stereotactic coordinates and can be digitized and displayed in available patient's modalities (CT, MR or Angiographic). The software can project the selected trajectory to any slices or sections and generate surgeon's eye views. For any possible needle position, the angle settings for either the Riechert/Mundinger (RM) or Zamorano/Dujovny (ZD) stereotactic operating devices can be displayed. Praezis Plus supports the transfer of stereotactic coordinates between angiographic, CT and MR images. Regions of Interest ("ROIs") and Volumes of Interest ("VOIs") can be defined, transferred and displayed between angiographic, CT and MR images. Their area and volume can be calculated. Global stereotactical transformation is available to improve the planning. Image fusion, based on various methods of correlation, allows a combination of valuable information from different modalities. Several types of reconstructed sections such as arbitrary, along and perpendicular to trajectory together with 3D reconstructions are also available. It is possible to print out all the images and protocols and together with patient data archive them on a CD. The output from Praezis Plus is a printed stereotactical plan defining the trajectory and the setup of the stereotactical device. The treatment plans may be used to administer treatments after review and approval by the neurosurgeon.
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