Duns Number:071991843
Device Description: NovaPACS™ is a picture archiving and communication system software that retrieves, archive NovaPACS™ is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS™ contains WorkstationOne™ software developed by Three Palm Software and branded as NovaMG™ with WorkstationOne™ for softcopy reading and interpretation of digital mammography images by Radiologists.
Catalog Number
-
Brand Name
NovaMG™
Version/Model Number
NovaMG 1.8.2
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
-
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
d0dfc4c7-6c0d-4ba5-8ea7-c782c5dc87de
Public Version Date
May 23, 2019
Public Version Number
4
DI Record Publish Date
January 13, 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 |