BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil

    K Number: K181948 · Decision Nov 16, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    7
    Review Days
    119

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    Basic Information

    Device Name
    1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
    K Number
    K181948
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rapid Biomedical GmbH
    Date Received
    July 20, 2018
    Decision Date
    November 16, 2018
    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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