BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    VERITON NM

    K Number: K180514 · Decision Apr 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    8
    Review Days
    57

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    Basic Information

    Device Name
    VERITON NM
    K Number
    K180514
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectrum Dynamics Medical, Ltd.
    Date Received
    February 27, 2018
    Decision Date
    April 25, 2018
    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 Spectrum Dynamics Medical, Ltd.

    K Number Device Name
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    K253532 TruSPECT Processing Station
    K230600 VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
    K212230 TruSPECT Radiological Image Processing Station
    K190457 VERITON CT whole body SPECT/CT system
    K182484 VERITON CT whole body SPECT/CT system
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