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

    ANTERIOR NECK CONTOUR COIL

    K Number: K905512 · Decision Mar 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    9
    Review Days
    87

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    Basic Information

    Device Name
    ANTERIOR NECK CONTOUR COIL
    K Number
    K905512
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Magnetic Research, Inc.
    Date Received
    December 10, 1990
    Decision Date
    March 7, 1991
    Product Code
    LNH
    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
    LNH System, Nuclear Magnetic Resonance Imaging

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    Other Clearances by Magnetic Research, Inc.

    K Number Device Name
    K935015 QUADRATURE SMALL EXTREMITY COIL
    K932552 SPORTS MEDICINE QUADRATURE SHOULDER COIL
    K932091 PHASED ARRAY/BILATERAL QUADRATURE CONTOUR COIL
    K931795 TELERAD STAT
    K930991 BILATERAL TEMPORAL MANDIBULAR JOINT COIL
    K923881 QUADRATURE CERVICAL CONTOUR COIL
    K920227 QUADRATURE SHOULDER CONTOUR COIL
    K922006 QQUADRATURE LUMBAR CONTOUR COIL