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510(k) Data Aggregation

    K Number
    K090190
    Device Name
    WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM
    Manufacturer
    Date Cleared
    2009-10-09

    (256 days)

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

    NUCLEMED S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    WIN-NEUS ™ is planning system software for brain Stereotactic surgery such as biopsies and treatment of Parkinson disease. The WIN-NEUS ™ is intended to be used with Leksell Coordinate G Frame and Leksell Multi Purpose Stereotactic Arc systems.
    Device Description
    WIN-NEUS ™ is planning system software for brain Stereotactic Surgery. The user can load image patient studies from different image modalities (CT, MRI, etc) with or without fiducials, register them and define a variety of image fusions among them. A brain Atlas and tools for image segmentation are also available. Image reconstructions in axial, coronal and sagital planes can be used along with image reconstruction in planes along and orthogonal to the proposed track to avoid probe intersection with critical structures or vessels. Win-NEUS is a powerful tool for Stereotactic Surgery such as biopsies and treatment of Parkinson disease.
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    K Number
    K090182
    Device Name
    MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)
    Manufacturer
    Date Cleared
    2009-05-04

    (98 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    NUCLEMED S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MIRS ™ is used to create treatment plans for patients for whom radiation therapy has been prescribed. The system will calculate and display three dimensional radiation dose distributions within the patient for a given treatment plan set up. MIRS can be used for different treatment modalities of radiation therapy, such as conventional therapy, Conformal Radiation Therapy, Intensity Modulated Radiation Therapy, and Radiosurgery with Conic Collimators.
    Device Description
    MIRS ™ is used to create treatment plans for patients for whom external beam radiation therapy has been prescribed. MIRS is used to create three dimensional radiation dose distributions within the patient for a given treatment plan set up. MIRS (Module Integrated Radiotherapy System) is a modular patient treatment planning system for different treatment modalities of radiation therapy, from three dimensional radiotherapy to Conformal Radiation Therapy, Intensity Modulated Radiation Therapy and Conventional radiotherapy with Conic Collimators. MIRS supports any stereotactic frame. MIRS has automatic multimodality image registration, with and without fiducials. Besides 3D RMI and CT images studies with any orientation (axial, coronal or sagital), MIRS supports registration of functional RMI, PET and angiography.
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