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Found 5 results

510(k) Data Aggregation

    K Number
    K050622
    Device Name
    HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL
    Manufacturer
    MRI DEVICES CORPORATION
    Date Cleared
    2005-04-08

    (29 days)

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

    MRI DEVICES CORPORATION

    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 the wrist and hand that can be interpreted by a trained physician.
    Device Description
    Models HRW-63-8 and HRW-127-8 Wrist Array Coils
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    K Number
    K050621
    Device Name
    NVA-127-8-A NEUROVASCULAR ARRAY COIL
    Manufacturer
    MRI DEVICES CORPORATION
    Date Cleared
    2005-04-07

    (28 days)

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

    MRI DEVICES CORPORATION

    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 the head and neck when interpreted by a trained physician.
    Device Description
    Model NVA-127-8-A Neurovascular Array Coil
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    K Number
    K050514
    Device Name
    MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS
    Manufacturer
    MRI DEVICES CORPORATION
    Date Cleared
    2005-03-25

    (24 days)

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

    MRI DEVICES CORPORATION

    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 the foot and ankle that can be interpreted by a trained physician.
    Device Description
    Not Found
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    K Number
    K050299
    Device Name
    HRK-123 KNEE ARRAY COIL
    Manufacturer
    MRI DEVICES CORPORATION
    Date Cleared
    2005-02-24

    (17 days)

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

    MRI DEVICES CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used in conjunction with a Magnetic Resonance Scanner to produce images that can be interpreted by a trained physician.
    Device Description
    HRK-123 Knee Array Coil
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    K Number
    K042103
    Device Name
    NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL
    Manufacturer
    MRI DEVICES CORPORATION
    Date Cleared
    2004-08-16

    (12 days)

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

    MRI DEVICES CORPORATION

    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 the head and neck, that can be interpreted by a trained physician.
    Device Description
    Not Found
    Ask a Question

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