CANON INC.

FDA Device Registration & Listing · OTAWARA-SHI Tochigi, JP · Registration 9614698

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9614698
FEI Number
3002808382
Entity Name
CANON INC.
City/State/Country
OTAWARA-SHI Tochigi, JP
Establishment Address
1385, SHIMOISHIGAMI, OTAWARA-SHI Tochigi 324-8550, JP
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
CANON INC. (Owner Number: 8030410)
Owner / Operator Contact Address
30-2 SHIMOMARUKO, 3-CHOME,, OHTA-KU, JP-13 146-8501, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K241582
PMA Number
N/A

All Registered 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 Vantage Orian 1.5T MRT-1550 v6 with AiCE Reconstruction Processing Unit for MR 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) ICT Module (09D28-04) 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 Vantage Galan 3T, MRT-3020, V8 with AiCE Reconstruction Processing Unit for MR 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)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2026-04-27
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-29
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
QHJ Sensor, Glucose, Implanted, Non-Adjunctive Use Unknown Class 3 N/A 2023-07-12
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
QCD Continuous Glucose Monitor, Implanted, Adjunctive Use Unknown Class 3 N/A 2023-07-12
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-30
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-27
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-04-27
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-30
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-21
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-21
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-29
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-24
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-04-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-27
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-29
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-29
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2026-04-29
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-30
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-24
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-21
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-30
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-30
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2026-04-30
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-21
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-21
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-21
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-29
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-29
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-27
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-04-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-09
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2026-04-30
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2026-04-30
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-29
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-29
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-27
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-27
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-24
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-29
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2026-04-30
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2026-04-30
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2026-04-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-24
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-04-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-24
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-04-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-04-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-21
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-27
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-24
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-27
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2026-04-27
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2026-04-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-27
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2026-04-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-27
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-21
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-24
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-21
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-24
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-21
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-21
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2026-04-30
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2026-04-30
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-24
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2026-04-29
IYL Collimator, Dermatological, Therapeutic X-Ray Radiology Class 2 892.5900 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-30
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-04-29
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2026-04-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2026-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2026-04-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-27
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-27
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-21
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2026-04-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-27
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-04-27
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-29
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-21
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-24
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-30
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-27
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-04-27
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-04-30
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-04-30
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2026-04-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-27
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-04-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-27

Official Correspondent

No official correspondent registered.

US Agent Details

Orlando Tadeo Business: Canon Medical Systems USA, Inc. Email: otadeo@us.medical.canon Phone: (714) 7305000

Related Public Records

Same Entity

CANON INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004026651 CANON COMPONENTS, INC. KODAMA-GUN Saitama, JP
1000181430 CANON INC. Kawasaki Kanagawa, JP
3038614464 Canon.Inc OHTA-KU Tokyo, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K070563 Vidar Systems Corp. VIDAR VISION 2000 2007-03-16
K190691 Pixxgen Corporation Pixx2430 Digital Diagnostic X-Ray Receptor Panel 2019-04-04
K150150 Rayence Co., Ltd. 1717SGN / 1717SCN Digital Flat Panel X-ray Detector 2015-03-27
K140771 Philips Medical Systems Dmc GmbH PHILIPS ELEVA WORKSPOT 2014-04-25
K863853 Superior Medical Products EAZY COVERS 1987-03-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2009 Toshiba American Medical Systems Inc 2
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007 AGFA Corp. 2
CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-0001-2007 GE OEC Medical Systems, Inc 2
GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009 Philips Medical Systems North America Co. Phillips 2
NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010 Ge Healthcare 2
GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.

Similar Registrations

Registration Number Establishment Name Location
3016256852 KA IMAGING INC. Waterloo Ontario, CA
3011825597 FAIR MEDICAL CO.,LTD Kashiwa Chiba, JP
3038614464 Canon.Inc OHTA-KU Tokyo, JP
3003775006 FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office HANAMAKI-SHI Iwate, JP
1000181430 CANON INC. Kawasaki Kanagawa, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614698. Last updated year: 2026. Please use registration number 9614698 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.