MiniCATIQ+

GUDID 00860008443755

XORAN TECHNOLOGIES LLC

Cone beam computed tomography system, head/neck
Primary Device ID00860008443755
NIH Device Record Key1e8c1f39-596e-4b99-aa0f-c25efc06052b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiniCATIQ+
Version Model Number10040
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008443755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-10
Device Publish Date2024-10-02

Devices Manufactured by XORAN TECHNOLOGIES LLC

00860008443755 - MiniCATIQ+2024-10-10
00860008443755 - MiniCATIQ+2024-10-10
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

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