AccessGUDID - DEVICE: Xoran Workstation (00860290000391)

GUDID

Device Identifier (DI) Information

Brand Name: Xoran Workstation
Version or Model: v5.15.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: XORAN TECHNOLOGIES LLC

Primary DI Number: 00860290000391
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079255809 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58473	Diagnostic x-ray digital imaging system workstation application software	An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAS	X-Ray, Tomography, Computed, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210257	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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