| Primary Device ID | 00882916001025 |
| NIH Device Record Key | c61efdcd-dc21-4c46-8880-1733fb80c587 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StrokeSENS LVO |
| Version Model Number | v2.x |
| Company DUNS | 248028578 |
| Company Name | Circle Cardiovascular Imaging Inc |
| 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 | true |
| 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 | 00882916001025 [Primary] |
| HIBCC | B926SSSX10 [Previous] |
| 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 | 2025-02-13 |
| Device Publish Date | 2025-02-05 |
| 00882916001025 - StrokeSENS LVO | 2025-02-13StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (L VO) in head CTA images. StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow. Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care. |
| 00882916001025 - StrokeSENS LVO | 2025-02-13 StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA |
| 00882916000028 - cvi42 | 2024-01-23 |
| 00882916000523 - TruPlan | 2022-10-28 |
| 00882916000516 - TruPlan | 2021-03-09 |
| 00882916000004 - cvi42 | 2020-09-01 Cardiac MR & CT imaging software application |
| 00882916000011 - cvi42 | 2019-05-14 |
| 00088291600001 - cvi42 | 2018-03-29 Cardiac MR & CT imaging software application |