Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004198450

FEI Number

3004198450

Entity Name

Xoran Technologies, LLC

City/State/Country

Ann Arbor, MI, US

Establishment Address

5210 South State Road, Ann Arbor, MI 48108, US

Establishment Type(s)

Remanufacture Medical Device,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Xoran Technologies LLC (Owner Number: 10028111)

Owner / Operator Contact Address

5210 South State Street, Ann Arbor, MI 48108, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221230

PMA Number

N/A

All Registered Proprietary Names

xCAT xCATIQ xCAT XL xoran Xoran Technologies, Inc. Xoran Workstation XoranConnect MiniCAT 2D TRON

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2008-12-30
IWY	Holder, Head, Radiographic	Radiology	Class 1	892.1920	2009-01-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-06-01
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-12-30
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2020-12-09
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2022-08-12
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-08-12
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-08-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Xoran Technologies LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2014	Xoran Technologies, Inc.	2	Xoran Mini CT Scanner
Z-0037-2014	Xoran Technologies, Inc.	2	Xoran MiniCAT CT Scanner
Z-0038-2014	Xoran Technologies, Inc.	2	Xoran Minicat00202
Z-0039-2014	Xoran Technologies, Inc.	2	Xoran Minicat00158
Z-0040-2014	Xoran Technologies, Inc.	2	Xoran MiniCAT00202
Z-0041-2014	Xoran Technologies, Inc.	2	Xoran MiniCAT CT Scanner ID ENT00001

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3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP
2134213	CANON MEDICAL INFORMATICS, INC.	MINNETONKA, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004198450. Last updated year: 2026. Please use registration number 3004198450 when referencing this establishment in official correspondence.