XoranConnect

GUDID 00860290000384

XORAN TECHNOLOGIES LLC

Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software

• Primary Device ID: 00860290000384
• NIH Device Record Key: 56fa2954-db09-4a8e-8e1d-082e9155d426
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XoranConnect
• Version Model Number: v.6
• 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	00860290000384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073306

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2022-08-23
• Device Publish Date: 2022-08-15

On-Brand Devices [XoranConnect]

• 00860290000322: 5.2
• 00860290000384: v.6