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

    SOPHY NXT

    K Number: K913641 · Decision Dec 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    8
    Review Days
    126

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    Basic Information

    Device Name
    SOPHY NXT
    K Number
    K913641
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sopha Medical Systems, Inc.
    Date Received
    August 13, 1991
    Decision Date
    December 17, 1991
    Product Code
    KPS
    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
    KPS System, Tomography, Computed, Emission

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    Other Clearances by Sopha Medical Systems, Inc.

    K Number Device Name
    K952190 TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE
    K942837 DST-XL
    K921008 VECTOR SERIES
    K911346 SOPHYCAMERA DSX BODYTRAK
    K894931 SOPHYCAMERA DSX RECTANGULAR
    K872132 SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS
    K872297 DS-7 NUCLEAR MEDICINE GAMMA CAMERA