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510(k) Data Aggregation

    K Number
    K162651
    Device Name
    Breast BI 7 MR Coil Mammavention 3T
    Manufacturer
    MORAS MRI products GmbH
    Date Cleared
    2017-01-18

    (117 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MORAS MRI products GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of Breast Bl 7 MR Coil 3T Mammavention is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device transverse, sagittal, coronal ad oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and wire localization of lesions can be performed by a trained physician. The coil system Breast Bl 7 MR Coil Mammavention can be used with the following MRI systems: - 3T: Siemens 3T: Skyra, Skyra fit, Prisma, Prisma fit, Spectra
    Device Description
    The Breast BI 7 MR Coil 3T Mammavention described in this document has been designed, depending upon model type, for use with a SIEMENS MRI system with field strength of 3 T. The coil system serves solely as a receiving coil for the reception of high frequency signals from the hydrogen -('-H) nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device. The processing magnetization induces potential differences in the Breast Bl 7 MR Coil 3T Mammavention which are digitized and further processed in the MRT system
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