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
10001814301000181430CANON INC.1N2026-01-019-1,Imaikami-cho, Nakahara-ku Kawasaki Kanagawa JP 211-8501
30127615443012761544CANON INC.1N2026-01-0130-2 SHIMOMARUKO, 3-CHOME -- OHTA-KU Tokyo JP 146-8501

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
04987670100222INTERVENTIONAL ANGIOGRAPHY SYSTEM - INFX-8000V+1-8004211968xxx@xxx.xxx
049876701013594ch Flex SPEEDER - MJAJ-197A+1-8004211968xxx@xxx.xxx
04987670102493Vitrea Software Toshiba Package - This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name Vitrea Software Toshiba Package. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now Vitrea Software Package.+1-8004211968xxx@xxx.xxx
04987670103360Vantage Orian - MRT-1550+1-8004211968xxx@xxx.xxx
04987670106088CONVEX ARRAY TRANSDUCER - PET-835LA+1-8004211968xxx@xxx.xxx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3520681389947573K990490SSA-320A JUST VISION 200/ SSA-325A JUST VISIONIYO1999-03-02
3491301802450084K990490SSA-320A JUST VISION 200/ SSA-325A JUST VISIONIYO1999-03-02
3520681104607522K990134MULTISLICE 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
3491301068522977K260078Aquilion ServeSP (TSX-307B) V2.0JAK2026-03-13
3520681749652578K260078Aquilion ServeSP (TSX-307B) V2.0JAK2026-03-13
3520681322957970K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2026-03-27
3491301664393978K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2026-03-27
3520681105806303K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemIYN2026-01-20
3491301135762046K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemIYN2026-01-20
3520681972126761K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK2026-05-20
3491301040619372K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)OWB2026-03-10
3520681317708339K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)OWB2026-03-10
3491301403963225K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemIYN2025-10-31
3520681422421273K252074Aplio 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
3520682046823134K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAPJAK2025-09-26
3520681461826770K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingOWB2025-10-10
3491302049015617K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingOWB2025-10-10
3520681211360375K251370Cartesion Prime (PCD-1000A/3) V10.21KPS2025-12-01
3491301613379607K251370Cartesion Prime (PCD-1000A/3) V10.21KPS2025-12-01
3520681160330443K250901Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2025-07-22
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
3520681841392712K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramQIH2025-04-30
3520681017691468K243398CT Scanner TSX-501R/1 V11.1JAK2025-06-20
3491301061060362K243398CT Scanner TSX-501R/1 V11.1JAK2025-06-20
3520681220678334K243335Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2025-01-07
3491301508910214K243335Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRLNH2025-01-07
3491301864320268K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5IYN2025-05-13
3520682016200357K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5IYN2025-05-13
3520681550401388K242403Aquilion ONE (TSX-308A/3) V1.5JAK2024-12-23
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
3520681461311141K241582Aplio 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
3520682033585959K241496Vantage 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
3520681591346202K241049CANON Fundus Camera CR-10 (CR-10)HKI2024-05-15
3491301070732630K240705Vitrea Software Package, VSTP-002A V2.0LLZ2024-07-17
3520681539821977K240705Vitrea 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
3520681740818501K240238Vantage 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
3520681351181274K233334Aquilion Serve SP (TSX-307B/1) V1.3JAK2023-12-06
3520681229180799K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemIYN2024-01-24
3491301725043615K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemIYN2024-01-24
3520681776504772K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5OWB2024-08-30
3491301977343561K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5OWB2024-08-30
3491301595308677K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemIYN2023-11-21
3520682053934815K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemIYN2023-11-21
3520681268208444K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemJAK2024-04-02
3491301833764723K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemJAK2024-04-02
3491301097103818K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA2023-09-12
3520681844748008K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA2023-09-12
3520681029157940K231748Cartesion Prime (PCD-1000A/3) V10.15KPS2023-09-12
3491301705248363K231748Cartesion Prime (PCD-1000A/3) V10.15KPS2023-09-12
3520681430262821K231281Aquilion Serve (TSX-307A/1) V1.3JAK2023-09-19
3491301743201323K231281Aquilion Serve (TSX-307A/1) V1.3JAK2023-09-19
3520681803361613K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRLNH2023-08-30
3491301895309608K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRLNH2023-08-30
3520681084591083K223336Vitrea Software Package, VSTP-002ALLZ2023-01-09
3491301779638603K223336Vitrea Software Package, VSTP-002ALLZ2023-01-09
3491301686282104K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0IYN2023-03-31
3520682024271341K223017Aplio 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
3520681904993780K222968Vantage 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
3491301473866415K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iJAK2023-03-03
3520681599906414K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iJAK2023-03-03
105981887733907K222687Digital Radiography CXDI-Elite, Digital Radiography E1MQB2022-09-29
3520681599204240K222387Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2022-08-31
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
105981587783634K221620Digital Radiography CXDI-Elite, Digital Radiography E1MQB2022-06-14
3520681320309706K220986Aquilion Precision (TSX-304A/4) V10.10 with AiCEJAK2022-09-12
3491301521077248K220986Aquilion Precision (TSX-304A/4) V10.10 with AiCEJAK2022-09-12
3520681420867368K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3OWB2022-09-27
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
3520682065507875K220335Vantage 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
3520682066206735K220192Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2022-04-08
105981935764178K220098Digital Radiography CXDI-Pro, Digital Radiography D1MQB2022-02-04
105982016933058K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1MQB2022-01-24
3520681381255651K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001AJAK2022-06-16
3491301592725977K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001AJAK2022-06-16
3520681087576998K213305Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2021-12-01
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
3520681806855909K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5IYN2022-03-22
105981688394557K212553DIGITAL RADIOGRAPHY CXDI-Pro, D1MQB2021-09-09
3491301919700771K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5IYN2022-01-24
3520681950802327K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5IYN2022-01-24
3520681731727940K212056Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-08-04
3491301904767762K212056Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-08-04
3491301747406059K211828Aquilion Exceed LBJAK2021-09-10
3520681798829541K211828Aquilion Exceed LBJAK2021-09-10
3491301751070210K211633Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-07-22
3520681858606656K211633Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-07-22
3520681784590586K211037Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-05-17
3491301806991786K211037Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-05-17
3520681690882996K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2OWB2021-04-12
3491301932449406K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2OWB2021-04-12
3520681415760795K210340Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-04-01
3491302062035567K210340Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-04-01
3520681353713134K210164Vantage Elan 1.5T, MRT-2020, V6.0LNH2021-03-10
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
3520681547472743K203553Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-02-02
3491301454704290K203551Alphenix, INFX-8000V/B, /S, V9.1OWB2020-12-18
3520681691027044K203551Alphenix, INFX-8000V/B, /S, V9.1OWB2020-12-18
3491301307012656K203323Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-03-04
3520682027784797K203323Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-03-04
3520681326760836K203314Cartesion Prime (PCD-1000A/3) V10.8KPS2021-04-23
3491301487746259K203314Cartesion Prime (PCD-1000A/3) V10.8KPS2021-04-23
3520681320173715K203312Vitrea Software Package, VSTP-001ALLZ2021-02-16
3491301356708921K203312Vitrea Software Package, VSTP-001ALLZ2021-02-16
3520681278967911K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemJAK2021-03-24
3491301302626953K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemJAK2021-03-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAK1092026-05-20
LNH982026-03-27
IYN812026-01-20
OWB542026-03-10
MQB342022-10-17
LLZ182024-07-17
JAA162023-09-12
KPS142025-12-01
MOS122012-08-17
HKI82024-05-15
ITX82011-02-02
IYO62012-08-16
QIH22025-04-30
NFJ22020-09-25
OBO12019-07-24
CFR12017-10-19
HKX12011-09-20

PMN#

GUDID#

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