BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NeuroQ

    DI: B133NEUROQ402503120 · Model: 4.0.9993.r20250312 · SYNTERMED INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NeuroQ
    Primary DI
    B133NEUROQ402503120
    Version / Model
    4.0.9993.r20250312
    Company Name
    SYNTERMED INCORPORATED
    Labeler DUNS
    113727205
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-21
    Public Version
    1
    Public Version Date
    2025-03-31
    Public Version Status
    New
    Public Device Record Key
    b142814f-4ba3-4bbd-a471-39160e6ed345

    Device Description

    The NeuroQ™ 3.8- 4.0 program is used to regionally quantify activity in brain PET and SPECT scans using a ROI count method. It displays co-registered PET, SPECT and CT images, along with output from quantification of activities reflecting regional concentrations of FDG, amyloid imaging agents, SPECT perfusion and dopamine transporter radiotracers, relative to activities in any of several user-selected reference regions or whole brain. It provides for displaying and quantifying the regional differences between two PET or SPECT brain studies for the same patient, or the levels of amyloid imaging agents retained in specified brain regions of a patient, and for assisting the user in the examination of brain scans acquired for assessing differential diagnosis of neurodegenerative processes underlying symptoms of cognitive and movement disorders by comparing regional activity values to each other and to those in brain scans acquired for asymptomatic control subjects. These neurodegenerative processes can be Alzheimer’s disease, Lewy body dementia, Parkinson’s disease with dementia, vascular dementia, and frontotemporal dementia.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KPS System, Tomography, Computed, Emission

    GMDN Terms

    Code Name
    60724 Multidisciplinary medical image management software

    Identifiers

    Type ID
    Primary B133NEUROQ402503120