Duns Number:079255809
Device Description: Xoran Workstation is an image processing and viewing software for use with compatible radi Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation software provides tools for image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.
Catalog Number
-
Brand Name
Xoran Workstation
Version/Model Number
v5.15.5
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K210257
Product Code
OAS
Product Code Name
X-Ray, Tomography, Computed, Dental
Public Device Record Key
e0492d7b-0605-4fc2-bf9f-3ab1245f32ff
Public Version Date
June 24, 2021
Public Version Number
1
DI Record Publish Date
June 16, 2021
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. | 10 |