NeuroQ

Primary DI
B133NEUROQ412507140
Brand
NeuroQ
Company
SYNTERMED INCORPORATED
Model
4.1.0036-r20250714
Device description
The NeuroQ™ 3.8- 4.1 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.
Published
2025-08-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KPSSystem, Tomography, Computed, Emission

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPSSystem, Tomography, Computed, EmissionRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B133NEUROQ412507140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multidisciplinary medical image management softwareA software application intended to be used to receive, collect, store, and display a broad range of medical imaging and/or video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). Also referred to as an operating room (OR) integration software, it might be designed for holographic viewing of three-dimensional (3-D) images in conjunction with an appropriate headset or for real-time communication of diagnostic/surgical images, and might also enable the control of light settings of a device (e.g., microscope) for image acquisition.

Regulatory Flags#

DUNS number
113727205
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B133ECTB422606160Cardiac Toolbox4.2.9663.361922026-07-02
B133NEUROQ412605150NeuroQ4.1.0060-r202605152026-06-10
B133ECTB400Emory Cardiac Toolbox4.2.7003.285862020-11-12
B133ECTB422009110Emory Cardiac Toolbox4.2.7559.137472020-11-12
B133NEUROQ300NeuroQ3.82020-11-12
B133NEUROQ412601160NeuroQ4.1.0060-r202601162026-03-04
B133ECTB422512090Cardiac Toolbox4.2.9474.379282026-02-26
B133ECTB4225063000Emory Cardiac Toolbox4.2.9312.297702025-08-01
B133NEUROQ402505160NeuroQ4.0.9995-r202505162025-06-18
B133ECTB422503240Emory Cardiac Toolbox4.2.9214.185482025-03-26
B133NEUROQ402503120NeuroQ4.0.9993.r202503122025-03-21
B133NEUROQ40241250NeuroQ4.0.991.r112025-01-27
B133ECTB422403260Emory Cardiac Toolbox4.2.8851.244802024-04-15
B133ECTB42231102Emory Cardiac Toolbox4.28706.220362023-11-14
B133ECTB42221031Emory Cardiac Toolbox4.2.8339.225562023-04-24
B133ECTB422112080Emory Cardiac Toolbox4.27720.294732021-12-28
B133NEUROQ382112070NeuroQ3.80.20210429.1432552021-12-28
B133NEUROQ382104290NeuroQ3.80.20210429.1432552021-05-27
B133ECTB422102190Emory Cardiac Toolbox4.27720.294732021-02-28
B133NEUROQ1NeuroQ3.75.201710192018-06-29

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