BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Spectrum Dynamics Medical Ltd.

    Reg #: 3006209933 · FEI: 3006209933 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Spectrum Dynamics Medical Ltd.
    Registration Number
    3006209933
    FEI Number
    3006209933
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    22 Bareket St., North Industrial Park
    City
    Caesarea North Ind. Park Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K253532

    Owner / Operator

    Firm Name
    Spectrum Dynamics Ltd
    Operator Number
    10044347
    Address
    22 Bareket St. North Ind. Park, POB 3033
    City
    Caesarea
    State
    Northern
    Postal Code
    3079837
    Country
    IL
    Correspondent
    Igor Naroditsky

    US Agent

    Business Name
    Spectrum Dynamics Medical Inc
    Contact Name
    Jim Haisler
    Address
    301 N Cattlemen Rd., Suite 109
    City
    Sarasota
    State
    FL
    ZIP
    34232
    Country
    US
    Email
    [email protected]
    Phone
    941 2563660

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH
    System, Image Processing, Radiological LLZ
    System, Tomography, Computed, Emission KPS
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    TruCORR.AI TruCLEAR.AI TruSPECT.AI VERITON 300, VERITON 400 VERITON CT 64, VERITON CT 264 D-SPECT L Cardiac Scaner D-SPECT CARDIO D-SPECT VISTA TruSPECT VERITON NM, VERITON 200 VERITON CT 16, VERITON CT 216 VERITAS.AI

    Establishment Types

    Manufacture Medical Device