FDA.reportPublic FDA data

CANON INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
CANON INC.5N2026-01-0130-2 SHIMOMARUKO, 3-CHOME -- OHTA-KU Tokyo JP 146-8501
20205632020563Canon Medical Systems USA, Inc.1Y2026-01-012441 Michelle Dr TUSTIN CA US 92780
21342133001654007CANON MEDICAL INFORMATICS, INC.1N2026-01-015850 Opus Parkway Suite 300 MINNETONKA MN US 55343
29368562936856Canon Medical Diagnostics USA, Inc.1N2026-01-01630 Clyde Ct MOUNTAIN VIEW CA US 94043
10001814301000181430CANON INC.1N2026-01-019-1,Imaikami-cho, Nakahara-ku Kawasaki Kanagawa JP 211-8501
30028255843002825584CANON ELECTRON TUBES & DEVICES CO., LTD.1N2026-01-011385 SHIMOISHIGAMI Otawara-shi Tochigi JP 324-8550
30040266511000582291CANON COMPONENTS, INC.1N2026-01-013461-1 SHICHIHONGI, OAZA KAMISATO-MACHI KODAMA-GUN Saitama JP 369-0393
30066192203006619220Canon Medical Informatics A/S1N2026-01-01Krumtappen 4, Etage 3 Valby Hovedstaden DK DK-2500
30129831423012983142CANON VIRGINIA, INC. MEDICAL PRODUCTS GROUP (CVIMPG)1N2026-01-0112000 Canon Blvd Newport News VA US 23606
30170884973017088497Canon Medical Components U.S.A., Inc.1Y2026-01-012355 Main Street, Ste. 150 Irvine CA US 92614
30386144643038614464Canon.Inc1N2026-01-0130-2, SHIMOMARUKO 3-CHOME, OHTA-KU Tokyo JP 146-8501
10645041000649926Canon Medical Systems USA, Inc.1Y2020-04-25720 South Powerline Road Suite E Deerfield Bch FL US 33442
20291021000160799CANON U.S.A., INC.1Y2020-04-2515975 ALTON PKWY. IRVINE CA US 92618
24431272443127CANON U.S.A., INC.1Y2020-04-251 Canon Park Melville NY US 11747
96146983002808382Canon Medical Systems Corporation1N2020-04-251385, SHIMOISHIGAMI OTAWARA-SHI, TOCHIGI JP 324-8550

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04987670100734DIAGNOSTIC ULTRASOUND SYSTEM - TUS-X100+1-8004211968xxx@xxx.xxx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
519121160685960P030012IMAGECHECKER CT CAD SOFTWARE SYSTEMNRR2004-07-08
519121854379538K994283MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEMLNH2000-08-30
519121916784544K994282MRI- FLOW ANALYTICAL SOFTWARE PACKAGELNH2000-03-02
159761802450084K990490SSA-320A JUST VISION 200/ SSA-325A JUST VISIONIYO1999-03-02
3491301802450084K990490SSA-320A JUST VISION 200/ SSA-325A JUST VISIONIYO1999-03-02
519121162500017K990442ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3LLZ1999-05-11
159762002085635K990134MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI)JAK1999-03-19
3491302002085635K990134MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI)JAK1999-03-19
159761424940261K954590MAX-1000A/R1JAA1995-11-20
519121451644638K953259VOXELVIEWLLZ1995-11-24
389591779561961K934524MAST CLA ALLERGY SYSTEMDHB1994-03-07
159761018130170K931297GCA-7200AKPS1993-07-27
389591695994132K926420MAST CLA ALLERGY SYSTEMDHB1994-03-07
159761814082127K922364DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTIXR1992-09-04
389591070001918K914850CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGEDHB1991-12-09
389591706155069K910292MAST CLA ALLERGY SYSTEMDHB1991-04-05
389591793932573K843694MAST ALLERGY SYSTEMDHB1985-04-12
389591478158964K841642MAST LUMINESCENT ALLERGY SYSDGC1984-06-07
389591269712277K834526MAST INHALANT PROFILEDHB1984-04-04
389591995152649K833969MAST TOTAL IGEDGC1984-01-04
389591845092057K833885MAST INHALANT PROFILEDHB1984-01-04
389591082224571K823593INHALANT PROFILE-ALLERGEN-SPECIFIC IGEDHB1983-02-25
3491301068522977K260078Aquilion ServeSP (TSX-307B) V2.0JAK2026-03-13
3491301664393978K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2026-03-27
3491301135762046K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemIYN2026-01-20
3491301040619372K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)OWB2026-03-10
519121119151121K252217CT VScore+JAK2025-11-28
3491301403963225K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemIYN2025-10-31
3491301793441227K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAPJAK2025-09-26
3491302049015617K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingOWB2025-10-10
3491301613379607K251370Cartesion Prime (PCD-1000A/3) V10.21KPS2025-12-01
3491301230956180K250901Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2025-07-22
3491301416388131K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramQIH2025-04-30
3491301061060362K243398CT Scanner TSX-501R/1 V11.1JAK2025-06-20
3491301508910214K243335Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2025-01-07
519121470356444K243240Vitrea CT VScoreJAK2025-04-10
3491301864320268K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5IYN2025-05-13
3491301746527719K242403Aquilion ONE (TSX-308A/3) V1.5JAK2024-12-23
3491301157002033K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)IYN2024-09-12
3491301037419945K241496Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2024-08-20
105981591346202K241049CANON Fundus Camera CR-10 (CR-10)HKI2024-05-15
105991591346202K241049CANON Fundus Camera CR-10 (CR-10)HKI2024-05-15
3396281591346202K241049CANON Fundus Camera CR-10 (CR-10)HKI2024-05-15
3491301070732630K240705Vitrea Software Package, VSTP-002A V2.0LLZ2024-07-17
3491301702060131K240238Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MRLNH2024-04-12
3491301194189508K233334Aquilion Serve SP (TSX-307B/1) V1.3JAK2023-12-06
3491301725043615K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemIYN2024-01-24
3491301977343561K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5OWB2024-08-30
3491301595308677K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemIYN2023-11-21
3491301833764723K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemJAK2024-04-02
3491301097103818K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA2023-09-12
3491301705248363K231748Cartesion Prime (PCD-1000A/3) V10.15KPS2023-09-12
3491301743201323K231281Aquilion Serve (TSX-307A/1) V1.3JAK2023-09-19
3491301895309608K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRLNH2023-08-30
3491301779638603K223336Vitrea Software Package, VSTP-002ALLZ2023-01-09
519121479546577K223261Open RibJAK2023-07-13
3491301686282104K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0IYN2023-03-31
3491301159254679K222968Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2022-10-25
105981049368179K222855Digital Radiography CXDI-Pro, Digital Radiography D1MQB2022-10-17
105991049368179K222855Digital Radiography CXDI-Pro, Digital Radiography D1MQB2022-10-17
3396281049368179K222855Digital Radiography CXDI-Pro, Digital Radiography D1MQB2022-10-17
3491301473866415K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iJAK2023-03-03
105981887733907K222687Digital Radiography CXDI-Elite, Digital Radiography E1MQB2022-09-29
105991887733907K222687Digital Radiography CXDI-Elite, Digital Radiography E1MQB2022-09-29
3396281887733907K222687Digital Radiography CXDI-Elite, Digital Radiography E1MQB2022-09-29
519121422111845K222662Vitrea CT Cardiac AnalysisLLZ2022-10-14
3491301894038399K222387Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2022-08-31
105981533196277K221876Digital Radiography CXDI-Pro, Digital Radiography D1MQB2022-07-15
105991533196277K221876Digital Radiography CXDI-Pro, Digital Radiography D1MQB2022-07-15
3396281533196277K221876Digital Radiography CXDI-Pro, Digital Radiography D1MQB2022-07-15
105981587783634K221620Digital Radiography CXDI-Elite, Digital Radiography E1MQB2022-06-14
105991587783634K221620Digital Radiography CXDI-Elite, Digital Radiography E1MQB2022-06-14
3396281587783634K221620Digital Radiography CXDI-Elite, Digital Radiography E1MQB2022-06-14
3491301521077248K220986Aquilion Precision (TSX-304A/4) V10.10 with AiCEJAK2022-09-12
3491301877432390K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3OWB2022-09-27
3491301393250192K220335Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2022-04-05
3491301709703300K220192Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2022-04-08
105981935764178K220098Digital Radiography CXDI-Pro, Digital Radiography D1MQB2022-02-04
105991935764178K220098Digital Radiography CXDI-Pro, Digital Radiography D1MQB2022-02-04
3396281935764178K220098Digital Radiography CXDI-Pro, Digital Radiography D1MQB2022-02-04
105982016933058K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1MQB2022-01-24
105992016933058K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1MQB2022-01-24
3396282016933058K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1MQB2022-01-24
3491301592725977K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001AJAK2022-06-16
3491301962506128K213305Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2021-12-01
3491301117628119K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5IYN2022-03-22
105981688394557K212553DIGITAL RADIOGRAPHY CXDI-Pro, D1MQB2021-09-09
105991688394557K212553DIGITAL RADIOGRAPHY CXDI-Pro, D1MQB2021-09-09
3396281688394557K212553DIGITAL RADIOGRAPHY CXDI-Pro, D1MQB2021-09-09
3491301919700771K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5IYN2022-01-24
3491301904767762K212056Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-08-04
3491301747406059K211828Aquilion Exceed LBJAK2021-09-10
3491301751070210K211633Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-07-22
3491301806991786K211037Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-05-17
3491301932449406K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2OWB2021-04-12
3491302062035567K210340Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-04-01
3491301472136874K210164Vantage Elan 1.5T, MRT-2020, V6.0LNH2021-03-10
3491301089559729K203553Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-02-02
3491301454704290K203551Alphenix, INFX-8000V/B, /S, V9.1OWB2020-12-18
3491301307012656K203323Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-03-04
3491301487746259K203314Cartesion Prime (PCD-1000A/3) V10.8KPS2021-04-23
3491301356708921K203312Vitrea Software Package, VSTP-001ALLZ2021-02-16
3491301302626953K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemJAK2021-03-24
3491301021913172K203053Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2020-12-02
3491301014502031K203042Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-IJAK2020-12-10
3491301334318857K202767Vantage Orian 1.5T, MRT-1550, V6.0LNH2021-01-15
3491301903330412K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1IYN2020-10-15
3491301812887484K202349Cartesion Prime, PCD-1000A, V10.7KPS2020-10-15
3491301403978375K202210Vantage Orian 1.5T, MRT-1550, V6.0LNH2020-09-22
3491301105977394K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1IYN2020-10-08
3491302013394259K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iJAK2021-01-12
105981080810829K201273ImageSPECTRUMNFJ2020-09-25
3396281080810829K201273ImageSPECTRUMNFJ2020-09-25
105981867955398K201122Canon non-mydriatic retinal camera CR seriesHKI2020-07-23
105991867955398K201122Canon non-mydriatic retinal camera CR seriesHKI2020-07-23
3396281867955398K201122Canon non-mydriatic retinal camera CR seriesHKI2020-07-23
3491301970873623K193097Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2020-07-14
3491301260751385K193021Vantage Orian 1.5T, MRT-1550, V6.0LNH2020-06-03
159761979182798K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iJAK2020-02-21
3491301979182798K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iJAK2020-02-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAK1052026-03-13
LNH812026-03-27
MQB802022-10-17
LLZ722024-07-17
IYN712026-01-20
OWB522026-03-10
HKI192024-05-15
KPS162025-12-01
JAA162023-09-12
DHB122019-03-19
MOS122012-08-17
ITX82011-02-02
IYO62012-08-16
NFJ42020-09-25
OBO32019-07-24
HKX32011-09-20
DQK22011-05-24
DGC21984-06-07
QIH12025-04-30
KPR12009-02-13
OEB12007-12-21
IXR11992-09-04

PMN#

Open Rib

2023-07-13

Canon Medical Informatics, Inc.

191 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next