Duns Number:266062561
Device Description: Senographe Pristina Core System
Catalog Number
-
Brand Name
Senographe Pristina
Version/Model Number
EKB4
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
K162268,P130020
Product Code
MUE
Product Code Name
Full field digital, system, x-ray, mammographic
Public Device Record Key
02d91563-1d48-4e5f-9d06-d74377597452
Public Version Date
October 04, 2022
Public Version Number
2
DI Record Publish Date
May 21, 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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| 3 | A medical device with high risk that requires premarket approval | 5 |