NeuroQ

GUDID B133NEUROQ382104290

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.

SYNTERMED INCORPORATED

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• Primary Device ID: B133NEUROQ382104290
• NIH Device Record Key: bad294d6-6cbd-4924-b630-67f69e67bf91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroQ
• Version Model Number: 3.80.20210429.143255
• Company DUNS: 113727205
• Company Name: SYNTERMED INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B133NEUROQ382104290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130451

FDA Product Code

• KPS: System, Tomography, Computed, Emission

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-04
• Device Publish Date: 2021-05-27

On-Brand Devices [NeuroQ]

• B133NEUROQ1: NeuroQ™ has been developed to aid in the assessment of human brain scans through quantificatio
• B133NEUROQ0: NeuroQ™ has been developed to aid in the assessment of human brain scans through quantificatio
• B133NEUROQ382104290: NeuroQ™ has been developed to aid in the assessment of human brain scans through quantificatio
• B133NEUROQ382112070: NeuroQ™ has been developed to aid in the assessment of human brain scans through quantificatio