xCAT XL

GUDID 00860290000346

XORAN TECHNOLOGIES LLC

Cone beam computed tomography system, head/neck
Primary Device ID00860290000346
NIH Device Record Key5f8c50b6-1b1e-49ec-bc6a-892b8a7a8cca
Commercial Distribution StatusIn Commercial Distribution
Brand NamexCAT XL
Version Model Number11010
Company DUNS079255809
Company NameXORAN TECHNOLOGIES LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860290000346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZLSystem, X-Ray, Mobile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-10

Devices Manufactured by XORAN TECHNOLOGIES LLC

00860008443731 - MiniCATIQ2024-02-06
00860008443748 - MiniCAT 2D2024-02-06
00860008443717 - Xoran Workstation2024-01-26 Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation softwar
00860008443724 - MiniCAT 2D2023-08-03 The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for us
00860290000384 - XoranConnect2022-08-23
00860290000391 - Xoran Workstation2021-06-24 Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation softwar
00860290000377 - MiniCAT 2D2020-12-22 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 IQ2019-06-25

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