| Primary Device ID | 06430070841021 |
| NIH Device Record Key | 0d0d1aba-45a4-4695-ba19-e5e061188c90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | cNeuro cMRI |
| Version Model Number | 2.0.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 | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 06430070841021 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-11 |
| Device Publish Date | 2021-11-03 |
| 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 | 2021-11-11https://www.combinostics.com/cmri/ |
| 06430070841021 - cNeuro cMRI | 2021-11-11 https://www.combinostics.com/cmri/ |