xCAT

GUDID 00860290000339

XORAN TECHNOLOGIES LLC

Cone beam computed tomography system, head/neck

• Primary Device ID: 00860290000339
• NIH Device Record Key: fd5a0379-fe8f-4d47-97cd-b1cef81d7251
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: xCAT
• Version Model Number: 11000
• 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	00860290000339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061834

FDA Product Code

• IZL: System, X-Ray, Mobile

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-28

Devices Manufactured by XORAN TECHNOLOGIES LLC

• 00860008443731 - MiniCATIQ: 2024-02-06
• 00860008443748 - MiniCAT 2D: 2024-02-06
• 00860008443717 - Xoran Workstation: 2024-01-26 Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation softwar
• 00860008443724 - MiniCAT 2D: 2023-08-03 The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for us
• 00860290000384 - XoranConnect: 2022-08-23
• 00860290000391 - Xoran Workstation: 2021-06-24 Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation softwar
• 00860290000377 - MiniCAT 2D: 2020-12-22 The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for us
• 00860290000360 - xCAT IQ: 2019-06-25