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Canon Medical Systems Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96146983002808382Canon Medical Systems Corporation1N2020-04-251385, SHIMOISHIGAMI OTAWARA-SHI, TOCHIGI JP 324-8550

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
159761802450084K990490SSA-320A JUST VISION 200/ SSA-325A JUST VISIONIYO1999-03-02
159762002085635K990134MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI)JAK1999-03-19
159761424940261K954590MAX-1000A/R1JAA1995-11-20
159761018130170K931297GCA-7200AKPS1993-07-27
159761814082127K922364DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTIXR1992-09-04
159761979182798K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iJAK2020-02-21
159761996096428K192828Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemJAK2020-02-13
159761117231625K192506Vantage Galan 3T, MRT-3020, V6.0LNH2020-03-02
159761819990555K192188Aquilion ONE (TSX-306A/3) V10.0JAK2019-09-06
159761190947565K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0IYN2019-09-18
159761827053338K191662Vantage Orian 1.5T, MRT-1550, V4.5LNH2019-07-23
159761444604097K191582Cartesion PrimeKPS2019-08-13
159761416521987K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0IYN2019-07-19
159761533854971K191128Vantage Titan 3T, MRT-3010, V2.5LNH2019-06-26
159761942619194K183657Vantage Galan 3T, MRT-3020/A9, V5.0LNH2019-03-15
159761389703289K183046Aquilion ONE (TSX-305A/6) V8.9 with AiCEJAK2019-06-12
159762019866404K182901Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCEJAK2019-07-05
159761180029496K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1IYN2018-10-31
159761809482440K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemIYN2018-11-02
159761570383669K182546Alphenix, INFX-8000H/B, V8.0OWB2018-10-17
159761635638138K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemIYN2018-11-02
159761098893261K182415Alphenix, INFX-8000F/B, V8.0OWB2018-09-28
159761413872052K182282Vantage Orian 1.5T, MRT-1550, V4.5LNH2018-10-19
159761162640170K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034AJAK2018-09-14
159761517595411K181834Ultimax-i, DREX-UI80 (V1.60)OWB2018-07-19
159761982719238K181804Alphenix, INFX-8000C/B, V8.0OWB2018-08-02
159761854994655K181670Alphenix, INFX-8000V/B, V8.0OWB2018-07-25
159761617514707K181646Celesteion, PCA-9000A/3, V6.5JAK2018-11-16
159761199943168K181593Vantage Galan 3T, MRT-3020/A7, V5.0LNH2018-08-13
159761308034289K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0OWB2018-09-10
159761756521345K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemIYN2018-04-20
159761468593539K173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0JAK2018-02-23
159761232959538K173382Vantage Galan 3T, V4.6LNH2018-01-26
159761943122693K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4IYN2018-01-11
159761664494295K172878Vantage Titan 3T, MRT-3010/A7, M-Power GXLNH2017-11-17
159761299336532K172863Infinix-i, INFX-8000V, V7.0OWB2017-12-14
159761135072165K172646XIDF-AWS801, Angio Workstation, V7.0OWB2017-10-30
159761835282915K172276Xario 200 Diagnostic Ultrasound System V6.0IYN2017-12-12
159761323326811K172188Aquilion Prime SP, TSX-303B/1, v8.4JAK2017-10-06
159761045832471K171597Vantage Elan 1.5T, V4.0LNH2017-07-21
159761911831649K171222Vitrea Software Toshiba Package; VSTP-001ALLZ2017-06-08
159761935012063K170909Infinix INFX-8000V, V6.40OWB2017-06-16
159761817583599K170832Ultimax-i, DREX-UI80 V1.60OWB2017-07-21
159761342134081K170490Celesteion, PCA-9000A/3KPS2017-06-01
159761769084428K170412Vantage Titan 1.5T, MRT-1510, M-Power GXLNH2017-06-07
159761387066535K170177Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1JAK2017-06-30
159761091349053K170019Aquilion Lightning, TSX-036A/1, V8.4JAK2017-02-02
159761781128286K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1IYN2017-05-30
159761398777438K162614Infinix, INFX-8000V, V6.35OWB2016-10-17
159761713127619K162187Xario 100 Diagnostic Ultrasound System, V5.0IYN2016-09-30
159762063535992K162183Vantage Galan 3T, MRT-3020, V4.0LNH2016-11-25
159761667786568K162155Xario 200 Diagnostic Ultrasound System V5.0IYN2016-11-01
159761495173593K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0IYN2016-09-21
159761054829317K161009Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4JAK2016-07-22
159761556036671K160632Vantage Titan 1.5T, MRT-1510, V3.6 SoftwareLNH2016-08-23
159761099452392K160587Aquilion ONE (TSX-305A/3) V7.3JAK2016-06-09
159761155262375K153263Aquilion Lightning, TSX-035A/4 and /5, V7.0JAK2016-04-01
159761610062117K152785XIDF-AWS801, Angio Workstation, V6.20OWB2015-11-25
159761393666552K152697INFX-8000C, V6.20OWB2016-01-15
159761029905103K152696INFX-8000V, V6.20OWB2016-01-12
159761800375930K152371Vantage Titan 3TLNH2015-10-23
159761466160310K151833Aquilion Lightning (TSX-035A/2, V7.0)JAK2015-10-09
159761914576892K151673Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)JAK2015-11-27
159761689590881K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0IYN2015-07-09
159761845606195K151091Vitrea Software Toshiba Package, VSTP-001ALLZ2015-07-13
159761808103653K150967XIDF-AWS801, Angio Workstation, V6.10OWB2015-06-18
159761506151467K150427Vantage Titan 1.5T, V3.1, MRT-1510LNH2015-04-17
159761237079388K150003Aquilion LB, TSX-201A/3, V6.0JAK2015-03-19
159761111588475K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysJAK2015-05-15
159761128036550K143281Ultimax-iOWB2015-01-29
159761904980823K143225INFX-8000V with Wireless FootswitchOWB2015-01-09
159761507695948K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTJAK2015-01-12
159761184701555K143046Xario 100, V3.0IYN2014-11-19
159761127018871K143027Xario 200, V3.0IYN2014-11-20
159761202445898K143008Vantage Titan 3TLNH2015-04-09
159761419803502K142736XIDF-AWS801, Angio Workstation, v5.31OWB2015-03-11
159761341409914K142465Aquilion ONE Vision, v7.0JAK2015-03-10
159761189138056K141741AQUILION PRIME, V6.00JAK2014-11-26
159761360894308K141541XIDF-AWS801, ANGIO WORKSTATION, V5.31JAA2014-09-08
159761433441092K141472VANTAGE ELANLNH2014-09-19
159761057255814K141459APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0IYN2014-10-28
159761954702234K140729APLIO ARTIDA, V3.2IYN2014-05-23
159761706544147K140651CELESTEION, PCA-9000A/2KPS2014-06-11
159761230534611K134025AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CTJAK2014-09-05
159761955920529K133761APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0IYN2014-04-22
159761313067773K133553KALAREJAA2014-06-13
159761534236761K133535INFX-8000V, V5.30OWB2014-07-23
159761662970056K133497AQUILION ONE VISIONJAK2014-02-10
159761035295497K133277XARIO 100IYN2014-01-17
159761872402819K132813DUAL ENERGY SYSTEM PACKAGEJAK2014-02-06
159761010134671K132222AQUILION ONE VISION, V6.0JAK2013-11-07
159761425646675K132160VANTAGE TITAN 3TLNH2013-10-16
159761415009355K132106INFINIX ANGIO WORKSTATION W/DTS SOFTWAREJAA2013-11-12
159761873888890K131822ULTRAEXTEND USWS-900A V2.1 AND V3.1LLZ2013-07-23
159761367713748K131507XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-08-28
159761323130187K130645AQUILION PRIME, V5.00JAK2013-06-06
159761580870090K123992APLIO 500/400/300 V3.0IYN2013-02-06
159762026446456K123500AQUILION LB TRITON V4.91JAK2013-05-02
159761629927983K122842RADREX-I, SW V4.00 MODEL DRAD-3000EMQB2012-10-09
159761267006320K122613VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/USLNH2012-12-13
159761059652777K122491VIAMO SSA-640A V4.0IYN2012-09-13
159761713448674K122109AQUILION ONE VISION, V4.90JAK2012-09-21
159762042529248K121911OCTAVE SPEEDER SPINEMOS2012-08-17
159761144943928K121910OCTAVE SPEEDER HEADMOS2012-08-17
159761405951451K121577APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-06-22
159761656736897K121553AQUILION RXLJAK2012-07-26
159761309555482K121422APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEMIYO2012-08-16
159762037660597K121076ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGELLZ2012-10-09
159761028072771K120710AQUILION PRIMEJAK2012-04-06
159761752911328K120638VANTAGE TITANLNH2012-06-01
159761458793609K120546AQUILION PREMIUMJAK2012-06-13
159761096214282K120487VANTAGE TITAN 3TLNH2012-05-23
159761009939135K120073INFX-8000V WITHOWB2012-01-26
159761443019971K113466AQUILION ONEJAK2012-04-10
159761852283300K113093VANTAGE TITAN 3TLNH2012-01-13
159761694291271K113052INFINIX-CCIMQB2011-11-22
159761018635519K112989AQUILION CXLJAK2012-04-10
159761545573712K1123664CH FLEX SPEEDERMOS2011-09-15
159761427487296K112054INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000VJAA2011-08-05
159761942285112K112003VANTAGE TITAN HSRLNH2011-12-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAK402020-02-21
IYN302019-09-18
LNH272020-03-02
OWB202018-10-17
JAA82014-09-08
LLZ72017-06-08
MOS62012-08-17
KPS52019-08-13
MQB42012-10-09
ITX42011-02-02
IYO32012-08-16
KPR12009-02-13
IXR11992-09-04

PMN#

85 records. Showing 1-40. Next