MiniCAT 2D

GUDID 00860008443748

XORAN TECHNOLOGIES LLC

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00860008443748
• NIH Device Record Key: a5d3851a-a346-4e2b-94bf-46d2520bcc07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniCAT 2D
• Version Model Number: 10031
• 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: true
• 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	00860008443748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201825

FDA Product Code

• KPR: System, X-Ray, Stationary

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: 2024-02-06
• Device Publish Date: 2024-01-29

On-Brand Devices [MiniCAT 2D]

• 00860290000377: The device is a permanently installed diagnostic x-ray system for general radiographic x-ray ima
• 00860008443724: The device is a permanently installed diagnostic x-ray system for general radiographic x-ray ima
• 00860008443748: 10031