cNeuro cDAT

GUDID 06430070845012

cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data. cNeuro™ cDAT enables visual evaluation and quantification of 123 Ioflupane (DaTscan™) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of 123 Ioflupane (DaTscan™) images. cNeuro™ cDAT assists in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease or Dementia with Lewy Bodies (DLB). cNeuro cDAT has not been demonstrated to improve 123 ioflupane reader performance for distinguishing positive from negative patients. This device should not be used to deviate from 123 ioflupane dosing and administration instructions. Refer also to 123 ioflupane prescribing information for instructions.

Combinostics Oy

Radiology DICOM image processing application software

• Primary Device ID: 06430070845012
• NIH Device Record Key: 23a3154f-8424-4fbd-a23f-dc2357081c35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cNeuro cDAT
• 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	06430070845012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233908

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2025-03-05
• Device Publish Date: 2025-02-25

Devices Manufactured by Combinostics Oy

• 06430070845012 - cNeuro cDAT: 2025-03-05cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data. cNeuro™ cDAT enables visual evaluation and quantification of 123 Ioflupane (DaTscan™) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of 123 Ioflupane (DaTscan™) images. cNeuro™ cDAT assists in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease or Dementia with Lewy Bodies (DLB). cNeuro cDAT has not been demonstrated to improve 123 ioflupane reader performance for distinguishing positive from negative patients. This device should not be used to deviate from 123 ioflupane dosing and administration instructions. Refer also to 123 ioflupane prescribing information for instructions.
• 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: 2025-03-04 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/