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

    MODEL 8010; EXTREMITY SURFACE COIL

    K Number: K901092 · Decision Apr 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    152
    Registration Numbers
    152
    Same Product Code
    1071
    Applicant Total
    57
    Review Days
    29

    Basic Information

    Device Name
    MODEL 8010; EXTREMITY SURFACE COIL
    K Number
    K901092
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    MEDICAL ADVANCES, INC.
    Date Received
    March 7, 1990
    Decision Date
    April 5, 1990
    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 MEDICAL ADVANCES, INC.

    K Number Device Name
    K023084 MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
    K021433 MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
    K011608 MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL
    K010074 MODEL 455GE PHASED ARRAY WRIST COIL
    K003685 MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
    K003144 MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
    K000345 MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES
    K991724 QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64
    K991434 QUADRATURE WRIST COIL, MODEL 445PH-64
    K991113 `INEAR WRIST COIL, MODEL 440GE-09
    Search all 57 clearances from MEDICAL ADVANCES, INC. →