NeuroQ

Primary DI
B133NEUROQ300
Brand
NeuroQ
Company
SYNTERMED INCORPORATED
Model
3.8
Device description
NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
Published
2020-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130451000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130451000NEUROQ 3.6Syntermed, Inc.2013-05-17KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B133NEUROQ300PrimaryHIBCC0

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); 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B133NEUROQ412601160NeuroQ4.1.0060-r202601162026-03-04
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B133NEUROQ412507140NeuroQ4.1.0036-r202507142025-08-06
B133ECTB4225063000Emory Cardiac Toolbox4.2.9312.297702025-08-01
B133NEUROQ402505160NeuroQ4.0.9995-r202505162025-06-18
B133ECTB422503240Emory Cardiac Toolbox 4.2.9214.185482025-03-26
B133ECTB422403260Emory Cardiac Toolbox4.2.8851.244802024-04-15
B133NEUROQ402503120NeuroQ4.0.9993.r202503122025-03-21
B133NEUROQ40241250NeuroQ4.0.991.r112025-01-27
B133ECTB42231102Emory Cardiac Toolbox4.28706.220362023-11-14
B133ECTB42221031Emory Cardiac Toolbox4.2.8339.225562023-04-24
B133ECTB400Emory Cardiac Toolbox4.2.7003.285862020-11-12
B133ECTB422009110Emory Cardiac Toolbox4.2.7559.137472020-11-12
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
B133ECTB40Emory Cardiac Toolbox4.0.5121.180012016-04-07
B133NEUROQ0NeuroQ3.6.201311272016-04-07

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