cNeuro cPET aids physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans. The software aids in the assessment of human brain PET scans…
cNeuro cPET aids physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans. The software aids in the assessment of human brain PET scans enabling automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest and voxel-based maps of the brain. cNeuro cPET allows the user to generate information regarding relative changes in PET-FDG glucose metabolism. cNeuro cPET additionally allows the user to generate information regarding relative changes in PET brain amyloid load between a subject’s images and a normal database, which may be the result of brain neurodegeneration. PET co-registration and fusion display capabilities with MRI allow PET findings to be related to brain anatomy. cNeuro cPET aids physicians in the image interpretation of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline.
Who Else Makes It
Concentrated in Beijing (1), Shanghai (1), Guangdong (1).
Record
Regulatory record for cNeuro cPET | Listed by | Combinostics, Finland |
| FDA product code | KPS |
| Device type | System, Tomography, Computed, Emission |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1200 |
| Establishment | Manufacturer |
| 510(k) | K231576 |
| Record published | 2025-02-24 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| 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.