Duns Number:416060564
Device Description: Bilateral Four Channel Phased Array CAROTIDS COIL for bilateral MRI proton imaging of the Bilateral Four Channel Phased Array CAROTIDS COIL for bilateral MRI proton imaging of the carotids bifurcation.The Carotids Coil enables sub-millimeter resolution of the carotids lumen, vessel walls and atherosclerotic plaques.Compatible with GE Signa HDx 3T scanners.
Catalog Number
PACC-GS30-HDx
Brand Name
NA
Version/Model Number
PACC-GS30-HDx
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012491
Product Code
MOS
Product Code Name
Coil, Magnetic Resonance, Specialty
Public Device Record Key
f2d5de37-62ee-4496-bca5-33a33b075d8a
Public Version Date
March 05, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
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. | 7 |