Duns Number:313217003
Device Description: syngo.via VB10B"Stock Keeping Unit B" - product label DVD Media CoverThis unit contains th syngo.via VB10B"Stock Keeping Unit B" - product label DVD Media CoverThis unit contains the following registered Medical Devices:(1) syngo.via - GTIN 04056869007045(2) syngo.interventional - GTIN 04056869020518(3) syngo.CT Coronary Analysis - GTIN 04056869013855(4) syngo.CT Cardiac Function - GTIN 04056869013862(5) syngo.CT CaScoring - GTIN 04056869013879(6) syngo.CT Vascular Analysis - GTIN 04056869013886(7) syngo.CT Colonography - GTIN 04056869013893(8) syngo.CT Pulmo3D - GTIN 04056869013909(9
Catalog Number
-
Brand Name
syngo.via
Version/Model Number
11250036
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
K150843
Product Code
LLZ
Product Code Name
System, image processing, radiological
Public Device Record Key
5140d92a-9c41-4df9-beeb-952769d61c41
Public Version Date
November 17, 2021
Public Version Number
7
DI Record Publish Date
September 24, 2016
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. | 478 |
| 3 | A medical device with high risk that requires premarket approval | 1 |