Xoran Workstation

GUDID 00860290000391

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.

XORAN TECHNOLOGIES LLC

Diagnostic x-ray digital imaging system workstation application software

• Primary Device ID: 00860290000391
• NIH Device Record Key: e0492d7b-0605-4fc2-bf9f-3ab1245f32ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xoran Workstation
• Version Model Number: v5.15.5
• Company DUNS: 079255809
• Company Name: XORAN TECHNOLOGIES LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860290000391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210257

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-24
• Device Publish Date: 2021-06-16

On-Brand Devices [Xoran Workstation]

• 00860290000391: Xoran Workstation is an image processing and viewing software for use with compatible radiograph
• 00860008443717: Xoran Workstation is an image processing and viewing software for use with compatible radiograph