cNeuro cPET

GUDID 06430070844015

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.

Combinostics Oy

Radiology DICOM image processing application software

• Primary Device ID: 06430070844015
• NIH Device Record Key: a6fcd284-ec7a-4998-85ec-93a51b408853
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cNeuro cPET
• Version Model Number: 1.0.x
• Company DUNS: 368347547
• Company Name: Combinostics Oy
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430070844015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231576

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: 2025-03-04
• Device Publish Date: 2025-02-24

Devices Manufactured by Combinostics Oy

• 06430070845012 - cNeuro cDAT: 2025-03-05 cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processi
• 06430070844015 - cNeuro cPET: 2025-03-04cNeuro 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.
• 06430070844015 - cNeuro cPET: 2025-03-04 cNeuro cPET aids physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans. The s
• 06430070841021 - cNeuro cMRI: 2021-11-11 https://www.combinostics.com/cmri/