Duns Number:965399905
Device Description: The device is intended as a computer platform to perform computation, display, connectivit The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen.
Catalog Number
CG-CORE-13
Brand Name
Clear Guide CORE
Version/Model Number
CGCORE13
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
-
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
K201898,K201898
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
6ae869dc-5a4a-43ae-9eb4-78b22c031706
Public Version Date
October 25, 2022
Public Version Number
2
DI Record Publish Date
October 06, 2022
Package DI Number
B201CGCORE131
Quantity per Package
1
Contains DI Package
B201CGCORE130
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |