MiniCAT 2D

GUDID 00860008443724

The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for use in hospitals, clinics, medical imaging centers, and medical practices.

XORAN TECHNOLOGIES LLC

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• Primary Device ID: 00860008443724
• NIH Device Record Key: 8afbd844-7ced-4a11-84b1-8c63bc491702
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniCAT 2D
• Version Model Number: 10035
• 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	00860008443724 [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: 2023-08-03
• Device Publish Date: 2023-07-26

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