BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    CANON INC.

    Reg #: 9614698 · FEI: 3002808382 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    213
    Establishment Types
    2
    Classifications
    18

    Registration Details

    Registration Name
    CANON INC.
    Registration Number
    9614698
    FEI Number
    3002808382
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1385, SHIMOISHIGAMI
    City
    OTAWARA-SHI Tochigi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K113052

    Owner / Operator

    Firm Name
    CANON INC.
    Operator Number
    8030410
    Address
    30-2 SHIMOMARUKO, 3-CHOME,
    City
    OHTA-KU
    State
    Tokyo
    Postal Code
    146-8501
    Country
    JP

    US Agent

    Business Name
    Canon Medical Systems USA, Inc.
    Contact Name
    Orlando Tadeo
    Address
    2441 Michelle Dr.
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    714 7305000

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    System, X-Ray, Tomography, Computed JAK
    Sensor, Glucose, Implanted, Non-Adjunctive Use QHJ
    Continuous Glucose Monitor, Implanted, Adjunctive Use QCD
    System, Tomography, Computed, Emission KPS
    System, Nuclear Magnetic Resonance Imaging LNH
    Coil, Magnetic Resonance, Specialty MOS
    System, X-Ray, Angiographic IZI
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    System, Image Processing, Radiological LLZ
    Hexokinase, Glucose CFR
    Collimator, Dermatological, Therapeutic X-Ray IYL
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    Infinix 8000C with Spot Fluoro XIDF -AWS801 v7 Angio Workstation XARIO 100 DIAGNOSTIC ULTRASOUND SYSTEM, V5 Aquilion Exceed LB (TSX-202A/3) v10.6 with AiCE-1 Eversense Continuous Glucose Monitoring System; Eversense E3 Continuous Glucose Monitoring System Viamo c100 TUS-VC-100 Diagnostic Ultrasound System INFX-8000V (Infinix Vfi & Infinix Cfi) v5.30 Cartesion Prime PCD-1000A Ultimax 1 FPD DREX-U180 Aplio Artida v3.2 SSH-880CV Viamo v4 SSA-640 TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING AQUILION ONE (TSX-305A/3) V8.3 WITH FIRST 2.1 Vantage Titan MRT-1510 v4 M Power GX Aplio 500/400/300 v4 Diagnostic Ultrasound System Angio Workstation (Alphenix Workstation), V9.3 AQUILION LIGHTNING (TSX-036A/7) V10.2 WITH AICE-I MJQJ-167A Vantage Galan 3T MRT-3020 v4 VANTAGE ELAN 1.5T, MRT-2020, V6 INFX-8000v v6.40 Kalare X-Ray System (DREX-KL80) Kalare with FPD (DREX-KL80) Aquilion One Genesis TSX-305A/3 v7.3 Aplio i900/i800/i700/i600 (TUS-AI900, TUS-AI800, TUS-AI700, TUS-AI600) Diagnostic Ultrasound System v2.4 Vantage Titan 1.5 MRT-1510 v3.1 Aplio A500/A400/A300 Vantage Orian 1.5T MRT-1550 v6 with AiCE Reconstruction Processing Unit for MR DUAL ENERGY SYSTEM PACKAGE INFX-8000V v6.20 Alphenix INFX-8000F/B v8 APLIO A550, APLIO A450, APLIO A, DIAGNOSTIC ULTRASOUND SYSTEM, SOFTWARE V5.1 Just Vision SSA320A/SSA-325A Aquilion One Self Propelled Scan Base Kit for IVR-CT (TSX-301C) XIDF-AWS801 v4.51 Angio Workstation Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i Aquilion LB Triton TSX-201A/2 v4.91 AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM Vantage Galan 3T, MRT-3020, V8 with AiCE Reconstruction Processing Unit for MR Xario XG SSA-680 Aplio Artida V2 SSH-880CV Ultimax-i DREX-UI80 v1.60 (with TFP-1417W Wireless Detector) Vantage Galan 3T, MRT-3020, V9 with AiCE Reconstruction Processing Unit for MR CARTESION PRIME, PCD-1000A, V10.7 Aplio i900/i800/i700 Diagnostic Ultrasound System v2.1 EC9-4; VF7-3; C5-2 (TMSC Contract Manufacturer for Siemens) Alphenix INFX-8000V/B v8 Aquilion Prime Self Propelled Scan Base Kit for IVR CT CGBA-032A TSX-303A Aplio XG v4 SSA-790A Aplio A550 (CUS-AA550) Aplio A450A (CUS-AA450) v2.8 Diagnostic Ultrasound System Aquilion Serve SP (TSX-307B) V2 Vantage Galan 3T,MRT-3020, V10 with AiCE Reconstruction Processing Unit for MR Xario 200 TUS-X200 and X200S v3 Architect c16000 Processing Module (03L77-01) Architect c8000 Processing Module (01G06-11) Architect c4000 Processing Module (02P24-40) Architect c4000 Processing Module (02P24-01) Vitrea Software Package, VSTP-002A Ultimax-I DREX-UI80 v1.60 VANTAGE ORIAN 1.5T, MRT-1550, V6 WITH AICE RECONSTRUCTION PROCESSING UNIT FOR MR VANTAGE GALAN 3T, MRT-3020, V7 WITH AICE RECONSTRUCTION PROCESSING UNIT FOR MR Excelart Vantage Atlas, MRT 1503/S5 & S3 AQUILION ONE (TSX-306A/3) V10.4 WITH SPECTRAL IMAGING SYSTEM Xario 100 v1 TUS-X100 & TUSX-100S Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) ICT Module (09D28-04) Alinity C Processing Module (03R67-01) Vantage Fortian 1.5T, MRT-1550, v8 with AiCE Reconstruction Processing Unit for MR AQUILION ONE (TSX-306A/3) V10 WITH SPECTRAL IMAGING SYSTEM Vantage Titan MRT-3010/A5 v2.30 MJAH-137A Atlas Speeder Coil Aplio beyond and Aplio me Software V2 Diagnostic Ultrasound System Xario 200 (TUS-X200, TUS-X200S) Diagnostic Ultrasound System v 6 Aquilion One TSX-301A CT w/4.7ER Software CARTESION PRIME (PCD-1000A/3) V10.15 Aquilion One Vision TSX-301C/3, C/4, C5 V6 Vantage Fortian / Orian 1.5T, MRT-1550, V10 with AiCE Reconstruction Processing Unit for MR Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP Aplio 500/400/300 Diagnostic Ultrasound System, v5 INFX-8000V, INFINIX-CFI AND INFINIX VFI Infinix-CSi and Infinix DPi, INFX-8000F VITREA SOFTWARE PACKAGE, VSTP-001A Aplio A500/A400/A300 (V2.1) Vantage Galan 3T, MRT-3020, V10 with AiCE Reconstruction Processing Unit for MR Aquilion One (TSX-306A/3) v10 Aplio 500/400/300 (v3) Aplio MX v1 SSA-780A Vantage Titan MRT-1504/U4 CT SCANNER TSX-501R/1 V11.1 Aplio i900/i800/i700/i600 (TUS-AI900, TUS-AI800, TUS-AI700, TUS-AI600) Diagnostic Ultrasound System v4 Vantage Fortian / Orian 1.5T, MRT-1550, V9 with AiCE Vantage Galan 3T MRT-3020 v6 with AiCE Reconstruction Processing Unit for MR Famio SSA-530A Alphenix, INFX-8000C/B, INFX-8000C/S v9.2 Aquilion One Vision TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v8 Aquilion Precision TSX-304A/2 v8.6 with First 3 Aplio 550a/450a/a Diagnostic Ultrasound System Models CUS-AA550/AA450/AA000 Aquilion Serve SP (TSX-307B/1) V1.3 Aplio 500/400/300 Diagnostic Ultrasound System, v6 Aquilion Premium (TSX-301B) Titan 3T MRT-3010/A5 (MRA) Vantage Galan 3T MRT-3020 V6 Alphenix INFX-8000C/B v8 Adaptive Motion Correction (AMC) and 4D Airways Analysis JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X Aquilion RXL (TSX-101A/R) Vantage Titan MRT-3010/A5 Vantage Titan 3T MRT-3010 v3.5 Vantage Orian 1.5T MRT-1550 v4.5 AQUILION PRIME (TSX-302) Vantage Elan MRT-2020 Nemio Diagnostic Ultrasound System Infinix-i INFX-8000H Aquilion Self Propelled Scan Base Kit for IVR-CT CGBA-034A AQUILION SERVE (TSX-307A/1) V1.3 Vantage Titan 3T MRT-3010/A5 Aplio i900 (TUS-AI900), Aplio i800 (TUS-AI800) and Aplio i700 (TUS-AI700) Software V8.1 Diagnostic Ultrasound System UltraExtend FX Aquilion Lightning TSX-035A/4 and/5 v7 Titan 1.5T with HSR Celestion PCA-9000A/2 VITREA SOFTWARE PACKAGE, VSTP-002A V2 Aquilion Prime CT TSX-302A/2 Alinity c Processing Module (03R67-01) Aquilion Exceed LB (TSX-202A/3) v10.9 with AiCE-i Aplio flex (CUS-AFL00) and Aplio go (CUS-AGG00) Software V2 Diagnostic Ultrasound System MJAS-167A Octave Speeder Spine Coil Aquilion LB TSX-201A/3 v6 Radrex-I DRAD-3000E v4 Vantage Fortian/Orian 1.5T, MRT-1550, V8 with AiCE Reconstruction Processing Unit for MR VANTAGE ORIAN 1.5T, MRT-1550, V7 WITH AICE RECONSTRUCTION PROCESSING UNIT FOR MR Vantage Titan AQUILION ONE (TSX-301C) UltraExtend, USWS-900A Cartesion Prime PCD-1000A/3 v10.8 with PET-AiCE Aquilion CXL TSX-101A/Q CELESTEION, PCA-9000A/3, V6.5 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 Aplio i900/i800/i700/i600 (TUS-AI900, TUS-AI800, TUS-AI700, TUS-AI600) Diagnostic Ultrasound System v3.1 AQUILION PRIME SP (TSX-303B8) V10.2 WITH AICE-I Xario 200 TUS-X200 and TUS-X200S v5 Xario 200G (CUS-X200G) and Xario 100G (CUS-X100G) v1.1 Diagnostic Ultrasound System Xario 200 TUS-X200/X200S v1 MJAH-167A Octave Speeder Head Coil Aquilion Prime SP TSX-303B/1, v8.4 Aquilion Prime TSX-303A/A, /B and F, v6 Viamo v2 SSA-640A XIDF-AWS801A Angio Workstation Alphenix Worksation v8 Nemio XG SSA-580 MJAJ-192A 4ch Flex Speeder Coil AQUILION LIGHTNING (TSX-035A/2, V7) Vantage Titan 3T MRT-3010 v2.5 INFX-8000C v6.20 Cartesion Prime (PCD-1000A/3) V10.21 INFX-8000V with 3DRM PET-512MC Multiplane Transesophageal Transducer APLIO I900/I800/I700 DIAGNOSTIC ULTRASOUND SYSTEM, SOFTWARE V7 (TUS-AI900, TUS-AI800, TUS-AI700) Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 Infinix-i, INFX-8000V, V7 Vantage Fortian/Orian 1.5 T, MRT-1550, V8 with AiCE Reconstruction Processing Unit for MR Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE Vantage Galan 3T MRT-3020/A9 v5 Vantage Orian 1.5T MRT-1550 v6 UltraExtend, USWS-900A, v2.1 and 3.1 Aplio i900, Aplio i800 and Aplio i700 Software V9 XIDF-AWS801 v5.31 Angio Workstation APLIO A550, APLIO A450, AND APLIO A, DIAGNOSTIC ULTRASOUND SYSTEM, SOFTWARE V6.5 Aquilion One Vision with First 1 (CCRS-001A) TSX-301C/6,/7,/8 v7.1 Aplio i900/i800/i700 (TUS-AI900, TUS-AI800, TUS-AI700) Diagnostic Ultrasound System, Software V5.1 Aplio v5.5 SSA-770A AQUILION ONE (TSX-306A/3) V10.12 WITH SPECTRAL IMAGING SYSTEM, VITREA SOFTWARE PACKAGE, VSTP-001A Aplio i900/i800/i700 (TUS-AI900/AI800/AI700) Vantage Galan 3T MRT-3020 v4.6 Aplio Artida V3 SSH-880CV MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM Aplio i900/i800/i700 (TUS-AI900, TUS-AI800, TUS-AI700) Diagnostic Ultrasound System v6.5 Aplio i900/i800/i700 (TUS-AI900, TUS-AI800, TUS-AI700)Diagnostic Ultrasound System, Software V7 AQUILION PRECISION (TSX-304A/4) V10.10 WITH AICE Aquilion ONE (TSX-308A/TSX-306A) V2 INFX-8000V v6.35 INFX-8000V Wireless FootSwitch XBFS-880WS Aquilion Prime TSX-303A/2 & TSX-303A/6 v50 VANTAGE GALAN 3T, MRT-3020, V6 WITH AICE RECONSTRUCTION PROCESSING UNIT FOR MR Vitrea Software Toshiba Package VSTP-001A Aquilion One Vision TSX-301C/1 and TSX-301C/2 v6 MJAJ-197A 4ch Flex Speeder Coil Vantage Titan 1.5T MRT-1510 v3.6 XIDF-AWS801 v6.20 Angio Workstation Aquilion ONE Vision with FIRST 2 (CCRS-001B) V7.4 Vantage Galan 3T MRT-3020 v7 SP0050* with AiCE Reconstruction Processing Unit for MR XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System XIDF-AWS801 v6.10 Angio Workstation Aquilion Lightning TSX-036A/1 v8.4 MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI) CELESTEION, PCA-9000A/3 Vantage Orian 1.5T MRT-1550 v7 with AiCE Reconstruction Processing Unit for MR Vantage Titan 3T MRT-3010/A7 M-Power GX TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER AQUILION ONE VISION, V4.90 (TSX-301C) Alphenix INFX-8000H/B v8 Vantage Elan 1.5T v4 Alphenix, INFX-8000V/S v9.1 Aquilion One (TSX-305A/6) v8.9 with AiCe VANTAGE ORIAN 1.5T, MRT-1550, V6 Xario 100 TUS-X100 and X100S v3 UltraExtend NX CUW-U001S Ultrasound Image Analysis Program Vantage Galan 3T MRT-3020/A7 v5 Vantage Titan MRT-1504/U5 Infinix V with 56 Inch Monitor USWP-100A/4D Viewer AQUILION ONE (TSX-308A/3) V1.5

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)