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510(k) Data Aggregation

    K Number
    K020289
    Device Name
    MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS
    Manufacturer
    MACHNET BV
    Date Cleared
    2002-04-24

    (86 days)

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

    MACHNET BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "MICS INTERVENTION AID (MICS-MIA and MICS-MIAS)" is for use in conjunction with a Magnetic Resonance Scanner and the Machnet Bilateral Open Breast Coil to localize lesions in female breasts and perform needle biopsies accurately. For use by a trained physician.
    Device Description
    The MR-Mammography Intervention Aid basically consists of a transparent acrylic plate containing about 600 puncture holes of 4 mm in diameter, held in a frame containing a set of MR fiduciary markers. The device can easily and firmly be attached to the Bilateral Open Breast Coil, thereby positioning and compressing the breast against a Breast Support Pad. The device comes with a (blue) Sliding Locator Plate for easy eyeretrieval of the software-established puncture hole, a detachable Fiduciary Marker Plate and sterilizable Needle Guide. The Mammography Intervention Aid comes with a PC-software package for supporting the calculation of the location and depth of puncturing. Information regarding the coordinates of a lesion and of the MR fiduciary markers should be retrieved from a relevant MR image and are input to the MICS software package. The software may calculate which hole to puncture through and how deep. A notebook PC with MIA Software Package installed is a system option
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    K Number
    K013985
    Device Name
    MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX
    Manufacturer
    MACHNET BV
    Date Cleared
    2002-02-01

    (60 days)

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

    MACHNET BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Machnet Bilateral Open Breast Coil, Catalog Number MICS-GSXX, is for use in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the breast and axillary tissues that can be interpreted by a trained physician.
    Device Description
    The Machnet Bilateral Open Breast Coil is designed as a bilateral open breast coil which allows clinical imaging combined with very precise multiple localizations of breast lesions and subsequently small interventional breast procedures. Features: Dual channel phased array configuration. Allows bilateral and unilateral imaging of the breast and surrounding tissues. Minimal variation of contrast across images. The design allows adequate reception of signals from chest wall and axilla Ergonomic design minimizes motion artifacts. Open coil design allows virtually all sizes of breasts to be imaged. Breast support and positioning devices allow controlled positioning. High sensitivity allows thin slices. Interventional MRI possible with optional device (MICS-MIA). Accurate (2 to 3 mm) multiple computer-assisted localizations of breast lesions (with MICS-MIAS). Compatibility: GE Signa® (3X-LX) 1.5T, 1.0T, 0.5T MR scanners.
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    K Number
    K012491
    Device Name
    MACHNET CAROTIDS COIL ARRAY ASSEMBLY
    Manufacturer
    MACHNET BV
    Date Cleared
    2001-10-24

    (82 days)

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

    MACHNET BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of Carotid structures that can be interpreted by a trained physician. The Machnet Carotids Coil is designed to provide coverage of the carotid arteries and associated vasculature from the aortic arch through the Circle-of-Willis. Anatomic Regions: Head and Neck Vasculature. Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The GE Signa system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon the density, spin lattice relaxation time Tl, spin-spin relaxation time T2) and (3) and (2) tissue. When interpreted by a trained physician, these images of the head and neck regions specifically the carotid arteries and association can be useful in the determination of a diagnosis.
    Device Description
    The Carotids Coil Array Assembly is a receive only coil array which consists of a dual set of coils electrically connected to a quick disconnect box which interfaces the assembly to the MR scanner. Each half of the coil assembly consists of two overlapping coils to buck out the mutual inductance between the coils. Active decoupling is achieved by PIN diodes which turn the coils to a high impedance state at transmit time. A pair of fast switching crossed diodes is installed in each coil segment acting as passive switches detuning the coils to further improve the safety of the Carotids Coil Array Assembly. Each transmission line has so called "bazooka baluns" installed to minimize the outer braiding currents on the coaxial cables. Coil diameter have been chosen to optimize sensitivity at distances to about 35 mm from the coil surface while a sharp cutoff beyond 40 mm from the surface minimizes the noise from volumes outside the region of interest. This ensures maximum signal ratio from the region of the carotids arteries.
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