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NeuroQ

FDA UDI

Class II (US FDA UDI)

by Syntermed Incorporated

Identity

Trade Name
NeuroQ FDA UDI
Generic Name
Multidisciplinary medical image management software FDA UDI
Device Name
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. FDA UDI
Model / Reference
4.0.991.r11 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
B133NEUROQ40241250 FDA UDI
FDA Product Code
KPS FDA UDI
GMDN Term
Multidisciplinary medical image management software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multidisciplinary medical image management software

NeuroQ by Syntermed Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multidisciplinary medical image management software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Syntermed Incorporated

Sources (1)

  • FDA UDI f224654a-07d6-4db4-9332-39d5b71628ff 33 fields · synced May 31, 2026