BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PEDIATRIC POSITIONER PAD SET

    K Number: K122174 · Decision Nov 16, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    8
    Applicant Total
    12
    Review Days
    116

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    Basic Information

    Device Name
    PEDIATRIC POSITIONER PAD SET
    K Number
    K122174
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1830
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Healthcare Coils (Usa Instruments, Inc.)
    Date Received
    July 23, 2012
    Decision Date
    November 16, 2012
    Product Code
    KXH
    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
    KXH Cradle, Patient, Radiologic

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    Other Clearances by Ge Healthcare Coils (Usa Instruments, Inc.)

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    K180666 48CH Head Coil
    K172695 AIR Anterior Array, AIR Posterior Array
    K163205 48CH Head Coil
    K143389 3.0T GEM RT Open Array
    K123327 1.5T GEM RT OPEN ARRAY
    K103365 DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A
    K101492 8 CHANNEL CARDIAC PHASED ARRAY COIL
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