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Xoran Technologies, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041984503004198450Xoran Technologies, LLC1Y2026-01-015210 South State Road Ann Arbor MI US 48108

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
980061008858667K221230TRONOWB2022-07-28
980061698418024K210257Xoran Workstation, Model 10050LLZ2021-05-20
980061099546799K201825MiniCAT 2DKPR2020-11-20
980062035203997K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)KPR2016-03-30
980061138925497K150725Visaris AvanseKPR2015-06-08
980061047896160K113421MINICATJAK2012-07-11
980061469695107K073306XORANCONNECTLLZ2008-01-07
980062049438770K061834XCAT; XCAT FOR NEUROJAK2006-08-07
980061903317577

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPR32020-11-20
LLZ22021-05-20
JAK22012-07-11
OWB12022-07-28

PMN#

TRON

2022-07-28

Xoran Technologies LLC

MINICAT

2012-07-11

XORAN TECHNOLOGIES, INC.

GUDID#

MiniCATIQ - MiniCATIQ is a compact, upright volume computed tomography system designed for highresolution,bone window imaging of the sinuses, temporal bones, and skull base.MiniCATIQ provides immediate access to images at the patient’s point-of-care resulting ina faster diagnosis and treatment.The MiniCATIQ is an X-ray imaging device that constructs a three-dimensional model ofthe head and neck from images taken during a rotational X-ray sequence. The MiniCATIQis optimized for the imaging of the maxillofacial complex, temporal bone, and sinuses.

XORAN TECHNOLOGIES LLC

2016-09-20