FDA.report

CANON MEDICAL INFORMATICS, INC.

Matched from indexed company URL: Canon Medical Informatics, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
21342133001654007CANON MEDICAL INFORMATICS, INC.1N2026-01-015850 Opus Parkway Suite 300 MINNETONKA MN US 55343

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
519121160685960P030012
519121854379538K994283MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEMLNH2000-08-30
519121916784544K994282MRI- FLOW ANALYTICAL SOFTWARE PACKAGELNH2000-03-02
519121162500017K990442ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3LLZ1999-05-11
519121451644638K953259VOXELVIEWLLZ1995-11-24
519121119151121K252217CT VScore+JAK2025-11-28
519121470356444K243240Vitrea CT VScoreJAK2025-04-10
519121479546577K223261Open RibJAK2023-07-13
519121422111845K222662Vitrea CT Cardiac AnalysisLLZ2022-10-14
519121620312756K191567
519121316449700K182230Multi Modality ViewerLLZ2018-09-07
519121542761327K181247Vitrea CT Brain PerfusionLLZ2018-11-20
519121508473492K180323Vitrea Software Package; VSTP-001ALLZ2018-03-30
519121713431857K173088Vitrea Software Toshiba Package VSTP-001ALLZ2018-01-31
519121609261583K172855Vitrea Advanced Visualization, Version 7.6LLZ2017-10-05
519121610619524K171222Vitrea Software Toshiba Package; VSTP-001ALLZ2017-06-08
519121559112902K163574Multi Modality ViewerLLZ2017-01-26
519121790104026K163232Vitrea ViewLLZ2017-07-21
519121297465117K161419Multi Modality ViewerLLZ2016-07-13
519121445197117K161157Vitrea CT Dual Energy Image ViewJAK2016-11-03
519121378398317K160150Vitrea CT Colon AnalysisLLZ2016-03-16
519121865085982K152602Olea Sphere V3.0LLZ2016-03-03
519121592559737K151919Vitrea CT Lung Density Analysis SoftwareJAK2015-10-10
519122037598602K151283Lung Analysis SoftwareJAK2015-10-30
519121137197334K151115MR Core SoftwareLLZ2015-06-03
519121365926803K151091Vitrea Software Toshiba Package, VSTP-001ALLZ2015-07-13
519121740589299K150738VitreaViewLLZ2015-04-06
519121525670760K150258Vitrea, Version 7.0 Medical Image Processing SoftwareLLZ2015-03-05
519121868228565K150122TOMTEC-ARENA TTA2LLZ2015-02-13
519121430903344K150104Vitrea CT Myocardial PerfusionJAK2015-04-17
519121491240604K143079Endovascular Stent Planning SoftwareLLZ2014-12-04
519121498798532K141652CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWAREKPS2014-07-22
519121485228139K141302VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)LLZ2014-08-01
519122033078265K140587MR-CT VVALLZ2015-01-06
519121210703562K140395VITREA IMAGE DENOISING SOFTWARELLZ2014-05-13
519121158365558K130393MIRADA RTXLLZ2013-03-20
519121835305063K123433CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWAREKPS2013-02-26
519121230382819K122578VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNINGLLZ2013-02-25
519121078324574K122136VITREAVIEWLLZ2012-09-07
519121660107763K121213VITREAADVANCEDLLZ2012-11-02
519122028824534K120196OLEA SPHERELLZ2012-04-19
519121123662737K1201352D CARDIAC PERFORMANCE ANALYSIS MR 1.0LLZ2012-04-13
519121486280202K113337VISIA DYNAMIC REVIEWLNH2011-12-30
519121199413181K112531VITREA CT MYOCARDIAL ANALYSISLLZ2011-11-18
519121528640095K112474CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWAREKPS2011-09-23
519121044046425K111892VITREAVIEW SOFTWARE 6.1LLZ2011-07-28
519121667673299K1107464D LV-ANALYSIS 3.0DQK2011-05-24
519121393797695K110667IMAGE-ARENA AND IMAGE-ARENA APPLICATIONSLLZ2011-04-08
519121087546184K1105954D SONO-SCAN 1.0LLZ2011-04-07
519122025456076K1037824D MV-ASSESSMENT 2.0DQK2011-01-27
519121867568448K102687MIRADA RTLLZ2010-10-04
519121604464488K101279CORRIDOR4DM V2010 MODEL: V2010LLZ2010-08-04
519121141869676K101228MIRADA XDLLZ2010-06-23
519121420881718K100714CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01KPS2011-04-01
519121006920676K092954CADSTREAM VERSION 5LLZ2009-11-06
519121332620353K091529ICAD VERALOOK CTC CAD SOFTWAREJAK2010-08-04
519121635083178K091498VITREA ENDOVASCULAR STENT PLANNING SOFTWARELLZ2009-06-05
519121072391051K091444PERFSCAPELNH2009-07-20
519121679560403K090461IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0LLZ2009-05-22
519121114595075K083491NEUROSCAPELLZ2009-02-19
519121994012227K073169SCIMAGE PICOMENTERPRISELLZ2008-01-09
519121866661574K073156QPLAQUE MRLNH2008-03-04
519121963900766K072821VITREA 4DCTLLZ2008-02-20
519121776083790K071362VITAL CONNECT 4.1LLZ2007-05-30
519121538547407K071331VITREA VERSION 4.0LLZ2007-05-25
519121834131097K071232IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONSLLZ2007-06-20
519121678361621K062328VITREAACCESS, VERSION 1.0LLZ2006-08-21
519121139984374K062154VITAL CONNECT 4.0LLZ2006-08-10
519121997840579K061624VITREA, VERSION 3.9LLZ2006-06-27
519121116266043K060378VITREA2 VERSION 3.8.1LLZ2006-03-09
519121116468137K052632VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARELLZ2005-12-15
519121925446672K043617IMAGECHECKER CT CAD SOFTWARE SYSTEMOEB2007-12-21
519121033088755K043333VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEMLLZ2004-12-15
519121309760882K040876ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARELLZ2004-04-19
519121082655924K040305VITREA2 VERSION 3.5LLZ2004-02-24
519121360932805K032748VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARELLZ2003-10-29
519121115768117K003639VITREA 2 CT PERFUSION OPTIONJAK2001-01-23
519121750021154K003230V SCORE WITH AUTO GATE MODEL TBDJAK2000-12-27
519121336255947K002519VITREA 2, VERSION 2.1LLZ2000-10-19
519121724628938K001682VSCORE WITH EKG SIGNAL GATINGJAK2000-06-30
519121861942765
519121967457822

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LLZ552022-10-14
JAK112025-11-28
LNH52011-12-30
KPS42014-07-22
DQK22011-05-24
OEB12007-12-21

PMA

PMN

Applications

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