BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LBS-127-16 BREAST ARRAY COIL

    K Number: K072874 · Decision Nov 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    6
    Review Days
    38

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    Basic Information

    Device Name
    LBS-127-16 BREAST ARRAY COIL
    K Number
    K072874
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Invivo
    Date Received
    October 9, 2007
    Decision Date
    November 16, 2007
    Product Code
    MOS
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MOS Coil, Magnetic Resonance, Specialty

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    Other Clearances by Invivo

    K Number Device Name
    K091902 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484
    K082987 HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL
    K082916 HRB-127-32 HIGH RESOLUTION BRAIN COIL
    K072873 LBS-63-16 BREAST ARRAY COIL
    K061952 CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16