Duns Number:491812076
Device Description: StrokeViewer LVO Triaging is a notification only cloud-based image processing software app StrokeViewer LVO Triaging 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.
Catalog Number
-
Brand Name
StrokeViewer LVO Triaging
Version/Model Number
3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200873,K211788
Product Code
QAS
Product Code Name
Radiological Computer-Assisted Triage And Notification Software
Public Device Record Key
82b2ff9c-a0b8-4072-b924-b2f7ad86db8a
Public Version Date
May 12, 2022
Public Version Number
2
DI Record Publish Date
March 08, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |