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

    TruSPECT Radiological Image Processing Station

    K Number: K212230 · Decision Aug 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    8
    Review Days
    31

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    Basic Information

    Device Name
    TruSPECT Radiological Image Processing Station
    K Number
    K212230
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectrum Dynamics Medical, Ltd.
    Date Received
    July 16, 2021
    Decision Date
    August 16, 2021
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

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    Other Clearances by Spectrum Dynamics Medical, Ltd.

    K Number Device Name
    K254001 VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
    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)
    K190457 VERITON CT whole body SPECT/CT system
    K182484 VERITON CT whole body SPECT/CT system
    K180514 VERITON NM
    K161740 D-SPECT Scanner, D-SPECT L Scanner