NeuroQ

GUDID B133NEUROQ402503120

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.

SYNTERMED INCORPORATED

Multidisciplinary medical image management software

• Primary Device ID: B133NEUROQ402503120
• NIH Device Record Key: b142814f-4ba3-4bbd-a471-39160e6ed345
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroQ
• Version Model Number: 4.0.9993.r20250312
• 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	B133NEUROQ402503120 [Primary]

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: 2025-03-31
• Device Publish Date: 2025-03-21

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
• B133NEUROQ40241250: The NeuroQ™ 3.8- 4.0 program is used to regionally quantify activity in brain PET and SPECT sc
• B133NEUROQ402503120: The NeuroQ™ 3.8- 4.0 program is used to regionally quantify activity in brain PET and SPECT sc
• B133NEUROQ402505160: The NeuroQ™ 3.8- 4.0 program is used to regionally quantify activity in brain PET and SPECT sc
• B133NEUROQ412507140: The NeuroQ™ 3.8- 4.1 program is used to regionally quantify activity in brain PET and SPECT sc