Duns Number:400793486
Device Description: icobrain is software intended for automatic labeling, visualization and volumetric quantif icobrain is software intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images.
Catalog Number
-
Brand Name
icobrain
Version/Model Number
2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161148
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
021db992-4cb7-413b-b01b-b5763f5af710
Public Version Date
October 07, 2019
Public Version Number
5
DI Record Publish Date
January 29, 2018
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. | 6 |