Duns Number:172223922
Device Description: ClearRead CT Console
Catalog Number
-
Brand Name
ClearRead CT Console
Version/Model Number
1.0.1.32
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 07, 2019
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
4b106f23-5054-4edf-b49a-8005ddbd7813
Public Version Date
May 11, 2022
Public Version Number
4
DI Record Publish Date
May 08, 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. | 221 |