Duns Number:532230094
Device Description: BriefCase is a radiological computer aided triage and notification software device. The de BriefCase is a radiological computer aided triage and notification software device. The device contains the software platform and image analysis algorithms for ICH, PE and CSF triage.
Catalog Number
-
Brand Name
BriefCase for ICH, PE and CSF triage
Version/Model Number
3.0.0
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
-
Product Code
QAS
Product Code Name
Radiological Computer-Assisted Triage And Notification Software
Public Device Record Key
ff074f1a-4755-4756-806e-07b43ef4269d
Public Version Date
November 25, 2019
Public Version Number
1
DI Record Publish Date
November 17, 2019
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. | 4 |