Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2134213

FEI Number

3001654007

Entity Name

CANON MEDICAL INFORMATICS, INC.

City/State/Country

MINNETONKA, MN, US

Establishment Address

5850 Opus Parkway Suite 300, MINNETONKA, MN 55343, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CANON MEDICAL INFORMATICS, INC. (Owner Number: 9024582)

Owner / Operator Contact Address

5850 OPUS PARKWAY, SUITE 300, Minnetonka, MN 55343, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121213

PMA Number

N/A

All Registered Proprietary Names

Vitrea CT VScore Vitrea Software Package; VSTP-001A Vitrea® CT Dual Energy Image View Olea Medical® Olea MR LC NeuroScape® Olea Medical® Olea MR CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE Vitrea Vitrea Pediatric package Vitrea LT Vitrea Oncology package XA Angio package Vitrea fX Toshiba International XA Angio fX package VitreaAdvanced fX Vitrea Enterprise Suite VitreaWorkstation fX Vitrea Cardiovascular package Vitrea Neurovascular package VitreaAdvanced VitreaWorkStation Medis® Cardiac MR QPlaque® VITREA IMAGE DENOISING SOFTWARE VitreaWorkStation Vitrea, Vitrea fX VitreaAdvanced Vitrea Enterprise Suite VitreaAdvanced fX Vitrea Cardiovascular package VitreaWorkstation fX Olea Medical® Olea MR LC PerfScape® Olea Medical® Olea MR Medis® Cardiac MR QFlow® MR Workstation TomTecImageArena Visia¿ Dynamic Review Vitrea View VitreaAdvanced fX CT Cardiac Functional Analysis Vitrea Oncology package CT Cardiac Analysis VitreaWorkstation fX Vitrea Enterprise Suite Vitrea LT General Vessel Probe Vitrea Cardiovascular package Vitrea Neurovascular package Vitrea Pediatric package Vitrea fX Vitrea VitreaWorkStation CT Multi-Chamber Cardiac Functional Analysis CT VScore CT Colon Analysis VitreaAdvanced VitreaCore ViTALConnect¿ Vitrea Cardiovascular package VitreaAdvanced VitreaWorkStation Vitrea Enterprise Suite VitreaWorkstation fX CT Endovascular Stent Planning VitreaAdvanced fX Vitrea, Vitrea fX MR Core TomTec Cardiac Ultrasound Advanced TomTec Cardiac Ultrasound Standard TomTec Radiology Ultrasound Standard TomTec Image Arena and Image Arena Applications VitreaView (Diagnostic) Vitrea View Vitrea Enterprise Viewer 7 TomTec Radiology Ultrasound Standard TomTec Cardiac Ultrasound Standard TomTec 4D SonoScan TomTec Cardiac Ultrasound Advanced TomTec Radiology Ultrasound Standard TomTec Cardiac Ultrasound Standard TomTec Cardiac Ultrasound Advanced TomTec 2D Cardiac Performance Analysis MR Open Rib Multi Modaliy Viewer iCAD® VeraLook CT Colon CAD Workflow Box WBX Mirada RTx Multi Modality Viewer Olea Sphere V3 Medis QFlow Medis Suite Medis QMass Vitrea Software Toshiba Package, VSTP-001A Vitrea Lung Analysis Mirada Oncology Fusion¿ PicomEnterprise Cedars Cardiac Suite MeVis Lung CAD Vitrea CT Colon Analysis Vitrea Enterprise Suite Vitrea Cardiovascular package VitreaAdvanced fX Vitrea, Vitrea fX VitreaWorkstation fX VitreaWorkStation VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS VitreaAdvanced Vitrea Oncology package CT Brain Perfusion VitreaAdvanced Vitrea LT Vitrea fX Vitrea Pediatric package MR Brain Tumor Analysis Vitrea Neurovascular package VitreaAdvanced fX XA Angio package CT VScore¿ VitreaWorkstation fX Vitrea Cardiovascular package Toshiba International XA Angio fX package Vitrea Vitrea Enterprise Suite VitreaWorkStation Vitrea CT Brain Perfusion TomTec Cardiac Ultrasound Advanced TomTec Cardiac Ultrasound Standard TomTec 4D LV Analysis TomTec Radiology Ultrasound Standard TomTec Radiology Ultrasound Standard TomTec Cardiac Ultrasound Advanced TomTec 4D MV Assessment TomTec Cardiac Ultrasound Standard Vitrea CT Cardiac Analysis Medis® Cardiac MR QMass® Medis QMass-Advanced Medis QMass-Essential Mirada XD Mirada NMx Vitrea LT VitreaWorkstation fX CT EP Planning Vitrea Cardiovascular package Vitrea Enterprise Suite CT SUREPlaque XA Angio package VitreaAdvanced fX Vitrea fX Vitrea Neurovascular package VitreaWorkStation VitreaAdvanced Vitrea Vitrea Oncology package VitreaExtend Vitrea Pediatric package Toshiba International XA Angio fX package General Vessel Probe Vitrea 7 Vitrea Advanced Visualization Vitrea Enterprise Suite CT Transcatheter Aortic Valve Replacement (TAVR) Vitrea VitreaAdvanced fX VitreaAdvanced VitreaWorkstation fX Vitrea fX VitreaWorkStation Vitrea View Multi Modality Viewer VitreaWorkstation fX Vitrea Neurovascular package Vitrea LT VitreaAdvanced Vitrea Enterprise Suite Vitrea, Vitrea fX VitreaWorkStation CT Brain Analysis 4D VitreaAdvanced fX Vitrea Software Toshiba Package, VSTP-001A CT Brain Perfusion Vitrea LT Toshiba International XA Angio fX package XA Angio package Vitrea Cardiovascular package CT Liver Analysis Vitrea Neurovascular package Vitrea Oncology package Vitrea Enterprise Suite Vitrea Pediatric package VitreaAdvanced fX CT Body Perfusion 4D for fX VitreaWorkstation fX Vitrea, VitreaWorkStation, Vitrea fX VitreaAdvanced

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	2025-12-19
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-08-08
IYL	Collimator, Dermatological, Therapeutic X-Ray	Radiology	Class 2	892.5900	2018-08-08
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-08-08
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-11-07
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-11-22
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2018-06-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-11-21
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-11-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-03-26
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-11-22
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-11-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-06-21
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-11-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-07-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-11-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2007-11-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-03-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-10-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-11-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-05-07
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-11-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-11-22
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-10-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-02-13
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-11-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-06-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-07-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-06-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-06-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-06-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-11-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-11-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-11-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-06-21
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2018-06-21
OEB	Lung Computed Tomography System, Computer-Aided Detection	Radiology	Class 2	892.2050	2018-06-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-03-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-03-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-11-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-12-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-11-22
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2013-11-22
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2013-11-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-10-06
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-11-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-06-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2007-11-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-03-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-11-22
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2019-07-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-12-10
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-06-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-12-04

Official Correspondent

Vincent Swenson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CANON MEDICAL INFORMATICS, INC.

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-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Similar Registrations

Registration Number	Establishment Name	Location
3011825597	FAIR MEDICAL CO.,LTD	Kashiwa Chiba, JP
3007233544	VIDA DIAGNOSTICS	Coralville, IA, US
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP
3009196578	LBN MEDICAL A/S	Aalborg Nordjylland, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2134213. Last updated year: 2026. Please use registration number 2134213 when referencing this establishment in official correspondence.