The following data is part of a premarket notification filed by Circle Neurovascular Imaging, Inc with the FDA for Strokesens Lvo.
| Device ID | K212261 |
| 510k Number | K212261 |
| Device Name: | StrokeSENS LVO |
| Classification | Radiological Computer-assisted Triage And Notification Software |
| Applicant | Circle Neurovascular Imaging, Inc Suite 1100 - 800 5th Avenue SW Calgary, CA T2p 3t6 |
| Contact | Kyle Mayr |
| Correspondent | Kyle Mayr Circle Cardiovascular Imaging, Inc. 800 5th Ave SW Suite 1100 Calgary, CA T2p 3t6 |
| Product Code | QAS |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-20 |
| Decision Date | 2021-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B926SSSX10 | K212261 | 000 |