Duns Number:194348913
Device Description: WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is alsointended for use as a comprehensive solution to view, optimize, and post-process diagnostic medicalimages as an aid to physicians and other healthcare professionals in the evaluation of digital imagingexaminations.
Catalog Number
n/a
Brand Name
WebPAX®
Version/Model Number
9
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
K152949
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
1eeedab3-5828-49df-b09e-136ea3728aaa
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 26, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |