FDA.reportPublic FDA data

CANON INC.

Matched from indexed company URL: 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
30386144643038614464Canon.Inc1N2026-01-0130-2, 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

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3491301802450084K990490SSA-320A JUST VISION 200/ SSA-325A JUST VISIONIYO1999-03-02
3491302002085635K990134MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI)JAK1999-03-19
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
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
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
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
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
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
3396281887733907K222687Digital Radiography CXDI-Elite, Digital Radiography E1MQB2022-09-29
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
3396281533196277K221876Digital Radiography CXDI-Pro, Digital Radiography D1MQB2022-07-15
105981587783634K221620Digital 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
3396281935764178K220098Digital Radiography CXDI-Pro, Digital Radiography D1MQB2022-02-04
105982016933058K213780DIGITAL 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
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
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
3491301979182798K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iJAK2020-02-21
3491301996096428K192828Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemJAK2020-02-13
105981801196088K192632DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C WirelessMQB2019-11-07
3396281801196088K192632DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C WirelessMQB2019-11-07
3491302033708447K192574Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2020-03-09
3491301117231625K192506Vantage Galan 3T, MRT-3020, V6.0LNH2020-03-02
3491301819990555K192188Aquilion ONE (TSX-306A/3) V10.0JAK2019-09-06
3491301190947565K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0IYN2019-09-18
3491301827053338K191662Vantage Orian 1.5T, MRT-1550, V4.5LNH2019-07-23
3491301444604097K191582Cartesion PrimeKPS2019-08-13
3491301416521987K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0IYN2019-07-19
3491301533854971K191128Vantage Titan 3T, MRT-3010, V2.5LNH2019-06-26
105981282862078K190368Enhanced Feature Software Pack CXDI SeriesMQB2019-03-13
3491301942619194K183657Vantage Galan 3T, MRT-3020/A9, V5.0LNH2019-03-15
3491301389703289K183046Aquilion ONE (TSX-305A/6) V8.9 with AiCEJAK2019-06-12
105982030665520K182942Canon OCT-A1OBO2019-07-24
3396282030665520K182942Canon OCT-A1OBO2019-07-24
3491302019866404K182901Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCEJAK2019-07-05
3491301180029496K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1IYN2018-10-31
3491301809482440K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemIYN2018-11-02
3491301570383669K182546Alphenix, INFX-8000H/B, V8.0OWB2018-10-17
3491301635638138K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemIYN2018-11-02
3491301098893261K182415Alphenix, INFX-8000F/B, V8.0OWB2018-09-28
3491301413872052K182282Vantage Orian 1.5T, MRT-1550, V4.5LNH2018-10-19
3491301162640170K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034AJAK2018-09-14
3491301517595411K181834Ultimax-i, DREX-UI80 (V1.60)OWB2018-07-19
3491301982719238K181804Alphenix, INFX-8000C/B, V8.0OWB2018-08-02
3491301854994655K181670Alphenix, INFX-8000V/B, V8.0OWB2018-07-25
3491301617514707K181646Celesteion, PCA-9000A/3, V6.5JAK2018-11-16
3491301199943168K181593Vantage Galan 3T, MRT-3020/A7, V5.0LNH2018-08-13
3491301308034289K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0OWB2018-09-10
3491301756521345K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemIYN2018-04-20
105981972743216K173689Ophthalmic Software Platform RXNFJ2018-02-23
3396281972743216K173689Ophthalmic Software Platform RXNFJ2018-02-23
3491301468593539K173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0JAK2018-02-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAK542026-03-13
MQB502022-10-17
LNH492026-03-27
IYN412026-01-20
OWB302026-03-10
HKI122024-05-15
LLZ92024-07-17
JAA82023-09-12
KPS72025-12-01
MOS62012-08-17
NFJ42020-09-25
ITX42011-02-02
IYO32012-08-16
OBO22019-07-24
HKX22011-09-20
QIH12025-04-30

PMN#

GUDID#

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