| Primary Device ID | 08720299502338 |
| NIH Device Record Key | 82b2ff9c-a0b8-4072-b924-b2f7ad86db8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StrokeViewer LVO detection |
| Version Model Number | 3.1 |
| 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 |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com | |
| Phone | +31202440852 |
| support@nicolab.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08720299502338 [Primary] |
| QAS | Radiological Computer-Assisted Triage And Notification Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-16 |
| Device Publish Date | 2022-03-08 |
| 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 | 2022-03-16StrokeViewer LVO detection is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation. |
| 08720299502338 - StrokeViewer LVO detection | 2022-03-16 StrokeViewer LVO detection is a notification only cloud-based image processing software application using artificial intelligenc |