Duns Number:413819707
Device Description: We’ve designed Ingenia 3.0T CX with the performance that helps you explore with confidence We’ve designed Ingenia 3.0T CX with the performance that helps you explore with confidence, perform advanced clinical imaging that supports referrals, and conduct routine imaging efficiently. Thanks in part to exceptional Qua
Catalog Number
782105
Brand Name
Ingenia
Version/Model Number
Ingenia 3.0T CX
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
K193215,K213516,K213583
Product Code
LNH
Product Code Name
System, nuclear magnetic resonance imaging
Public Device Record Key
ddc2db5e-4c69-4ae0-be91-cc0c8c8eadbc
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
May 01, 2021
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 |