Duns Number:160032025
Device Description: 1.5T Signa HDxt Upgrade Kit Medical Device, MDR
Catalog Number
-
Brand Name
NA
Version/Model Number
1.5T HD29
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121676
Product Code
LNH
Product Code Name
System, nuclear magnetic resonance imaging
Public Device Record Key
6deec774-303a-4c73-b553-88a5da01687f
Public Version Date
October 07, 2022
Public Version Number
2
DI Record Publish Date
May 10, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 81 |