Duns Number:313217003
Device Description: syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Application Softwa syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Application Software VD2
Catalog Number
-
Brand Name
syngo Application Software
Version/Model Number
11328180
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
K170747,K173611
Product Code
LLZ
Product Code Name
System, image processing, radiological
Public Device Record Key
aed10ccb-e60d-4b93-ac01-e0164142f757
Public Version Date
October 18, 2022
Public Version Number
1
DI Record Publish Date
October 10, 2022
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 |