cNeuro cDAT
Basic Information
- Brand Name
- cNeuro cDAT
- Primary DI
- 06430070845012
- Version / Model
- 1.0.x
- Company Name
- Combinostics Oy
- Labeler DUNS
- 368347547
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-25
- Public Version
- 1
- Public Version Date
- 2025-03-05
- Public Version Status
- New
- Public Device Record Key
- 23a3154f-8424-4fbd-a23f-dc2357081c35
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57812 | Radiology DICOM image processing application software | A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06430070845012 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233908 | 000 |