Duns Number:413819707
Device Description: The Ingenia Elition X with the gradient and RF designs, as well as Compressed SENSE delive The Ingenia Elition X with the gradient and RF designs, as well as Compressed SENSE delivers on superb image quality, improves patient handling setup time and combines this with accelerations in both 2D- and 3D scanning.
Catalog Number
782119
Brand Name
Ingenia
Version/Model Number
Ingenia Elition X
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
K213516
Product Code
LNH
Product Code Name
System, nuclear magnetic resonance imaging
Public Device Record Key
a53b9065-5d7d-4b9f-9ce5-2f3441a2d9da
Public Version Date
April 18, 2022
Public Version Number
1
DI Record Publish Date
April 08, 2022
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. | 349 |