BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TruSPECT

    Reg #: 3008007310 · FEI: 3008007310 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Spectrum Dynamics Medical Inc.
    Registration Number
    3008007310
    FEI Number
    3008007310
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    301 N. Cattlemen Rd. Suite 109
    City
    Sarasota
    State
    FL
    ZIP
    34232
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212230

    Owner / Operator

    Firm Name
    Spectrum Dynamics Medical, Inc.
    Operator Number
    10044466
    Address
    301 N. Cattlemen Rd. Suite 109
    City
    Sarasota
    State
    FL
    Postal Code
    34232
    Country
    US
    Correspondent
    Jim Haisler

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    TruSPECT

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198