The following data is part of a premarket notification filed by Ischemaview Inc. with the FDA for Rapid Lvo.
| Device ID | K200941 |
| 510k Number | K200941 |
| Device Name: | Rapid LVO |
| Classification | Radiological Computer-assisted Triage And Notification Software |
| Applicant | iSchemaView Inc. 433 Park Point Drive, Suite 220 Golden, CO 80401 |
| Contact | Jim Rosa |
| Correspondent | Jim Rosa iSchemaView Inc. 433 Park Point Drive, Suite 220 Golden, CO 80401 |
| Product Code | QAS |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-08 |
| Decision Date | 2020-07-09 |