Duns Number:266062561
Device Description: Digital Breast Tomosynthesis option for Senographe Essential
Catalog Number
5434135-4
Brand Name
SenoClaire
Version/Model Number
LLH1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 06, 2015
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
P130020
Product Code
OTE
Product Code Name
Digital Breast Tomosynthesis
Public Device Record Key
a687ca9a-d996-4f34-8c05-1c9225978e15
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2014
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 |