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

    DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A

    K Number: K103365 · Decision Jan 12, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    12
    Review Days
    56

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    Basic Information

    Device Name
    DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A
    K Number
    K103365
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Healthcare Coils (Usa Instruments, Inc.)
    Date Received
    November 17, 2010
    Decision Date
    January 12, 2011
    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 Ge Healthcare Coils (Usa Instruments, Inc.)

    K Number Device Name
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    K182504 3.0T Air MP M, 3.0T Air MP L
    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
    K122174 PEDIATRIC POSITIONER PAD SET
    K101492 8 CHANNEL CARDIAC PHASED ARRAY COIL
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