Duns Number:071991843
Device Description: A picture archiving and communication system software that retrieves, archives, distribute A picture archiving 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 8.9.1
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
f2a3700d-996d-4752-9606-d9f62a92cdf9
Public Version Date
April 26, 2022
Public Version Number
1
DI Record Publish Date
April 18, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |