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…
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.
Who Else Makes It
Concentrated in Beijing (1), Shanghai (1), Guangdong (1).
Record
Regulatory record for NeuroQ | Listed by | Syntermed, Inc., United States |
| FDA product code | KPS |
| Device type | System, Tomography, Computed, Emission |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1200 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K130451 |
| Record published | 2020-11-12 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.