cNeuro cPET
Combinostics Oy · Model 1.0.x · UDI-DI 06430070844015
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-24 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most eas |
| 2025-12-10 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affecte |
| 2025-12-10 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affecte |
| 2025-09-12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector |
| 2025-09-12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector |
| 2025-09-12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector |
| 2025-09-12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector |
| 2025-09-12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector |
| 2025-09-12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector |
| 2025-09-12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector |
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