| Primary Device ID | 08720299502352 |
| NIH Device Record Key | ba52c775-c1f6-4ea9-bf39-cf4c5d934982 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StrokeViewer Perfusion |
| Version Model Number | 1 |
| Company DUNS | 491812076 |
| Company Name | NICo-Lab B.V. |
| 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 | 08720299502352 [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 | 2023-12-28 |
| Device Publish Date | 2023-12-20 |
| 08720299502352 - StrokeViewer Perfusion | 2023-12-28StrokeViewer is an image processing software application that analyzes CT scans of the brain to provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients. |
| 08720299502352 - StrokeViewer Perfusion | 2023-12-28 StrokeViewer is an image processing software application that analyzes CT scans of the brain to provide quantitative perfusion i |
| 08720299502338 - StrokeViewer LVO detection | 2022-03-16 StrokeViewer LVO detection is a notification only cloud-based image processing software application using artificial intelligenc |