Duns Number:071991843
Device Description: A picture and communication system software that retrieves, archives, distributes, and dis A picture and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities.
Catalog Number
-
Brand Name
NovaPACS
Version/Model Number
NovaPACS 8.6.3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K171754
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
050dba16-bc11-46ed-82c1-d1cedca57c94
Public Version Date
May 23, 2019
Public Version Number
5
DI Record Publish Date
December 11, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |