FDA Registration
Inactive
🇯🇵 Japan
CANON INC.
·
Expires 2026
Products
14
Proprietary Names
204
Establishment Types
1
Classifications
14
Registration Details
- Registration Name
- CANON INC.
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 30-2 SHIMOMARUKO, 3-CHOME, --
- City
- OHTA-KU Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K210900
Owner / Operator
- Firm Name
- CANON INC.
- Operator Number
- 9021336
- Address
- 1385, SHIMOISHIGAMI, --
- City
- OTAWARA-SHI, TOCHIGI
- State
- JP-NOTA
- Postal Code
- 324-8550
- 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 protected]
- Phone
- 714 7305000 ext. 7459
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2021-04-14 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2026-01-30 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2026-01-30 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2026-01-30 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2016-06-02 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2012-10-12 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2019-07-03 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2019-07-15 |
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2020-12-01 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2008-11-03 |
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2011-10-26 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2017-07-17 |
| Collimator, Dermatological, Therapeutic X-Ray | IYL | Class 2 | Radiology | No | 2016-07-21 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2025-11-20 |
Proprietary Names
Alphenix INFX-8000C/B, INFX-8000C/S, v9.2
Aplio beyond and Aplio me Software V2 Diagnostic Ultrasound System
XIDF-AWS801 v6.20 Angio Workstation
Radrex-i DRAD-3000E v4
Vantage Titan 3T MRT-3010 v2.5
Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
Cartesian Prime PCD-1000A v10.7
Angio Workstation (Alphenix Workstation), V9.3
Aquilion LB Triton TSX-201A/2
Aplio TUS-A500/A400/A300 Diagnostic Ultrasound System
USWP-100A/4D Viewer
Infinix V
Vantage Galan 3T, MRT-3020, V8 with AiCE Reconstruction Processing Unit for MR
Alphenix INFX-8000V/B v8
Alphenix INFX-8000C/B v8
4CH Flex Speeder Coil MJAJ-192A
Xario 100 v1
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5
INFX-8000V v6.40
Viamo v4 SSA-640A
Xario 100 v5 Ultrasound System
Xario 200 Diagnostic Ultrasound System v6
UltraExtend FX
Aquilion CXL TSX-101A/Q
Dual Energy System Package, CSDP-001A
Aplio i900/i800/i700 Diagnostic Ultrasound System v6.5
Vantage Fortian / Orian 1.5T, MRT-1550, V9 with AiCE Reconstruction Processing Unit for MR
Aplio 500/400/300 Diagnostic Ultrasound System v4
Aplio flex and Aplio go Software V2 Diagnostic Ultrasound System
Aplio flex and Aplio go Transducers
Ultimax-i DREX-UI80 v1.60
Vantage Elan 1.5T v4
Aquilion One Vision with First 2 (CCRS-001B) v7.4
Aquilion One (TSX-305A/3) v8.3 with First 2.
Vantage Galan 3T, MRT-3020, V9
Vantage Fortian / Orian 1.5T, MRT-1550, V10 with AiCE Reconstruction Processing Unit for MR
Adaptive Motion Correction (AMC) and 4D Airways Analysis
Aquilion LB TSX-201A/3 v6
Aplio 500/400/300 Diagnostic Ultrasound System v6
Viamo v2 SSA-640A
Aplio v5.5 SSA-770A
Aplio i900, Aplio i800 and Aplio i700 Software V9
Vitrea Software Package, VSTP-002A
Aplio XG v4 SSA-790A
Vantage Titan 3T MRT-3010/A7 M-Power GX
Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP
Aquilion One
Aplio i900/i800/i700 Ultrasound System v2
Vantage Galan 3T MRT-3020 v6 with AiCE
CT Scanner TSX-501R/1 V11.1
UltraExtend
Aquilion ONE (TSX-305A/6) with AiCE
Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
Aquilion Exceed LB (TSX-202A/3) v10.6 with AiCE-1
JET Software
MJQJ-167A QD Knee/Foot Coil
Vantage Fortian 1.5T, MRT-1550, v8 with AiCE Reconstruction Processing Unit for MR
Titan 3T MRT-3010/A5
Aquilion Lightning TSX-035A/4 and /5 v7
Vantage Elan
Aplio a550, Aplio a450, Aplio a Diagnostic Ultrasound System v5.1
Aquilion 64 TSX-101A/H; A/I
Celesteion PCA-9000A/3 v6.5
INFX-8000V v6.35
Infinix-I Core +
Nemio XG
Vantage Titan 1.5T MRT-1510 v3.1
Vantage Titan 1.5T
Kalare
Aquilion ONE VISION TSX-301C/3, TSX-301C/4, TSX-301C/5
Vantage Titan 3T MRT-3010 v3.5
Aquilion Lightning TSX-035A/2 v7
Infinix 8000C
Just VISION SSA-320A/SSA-325A
Aplio Artida v3.2 SSH-880CV
Xario 200 TUS-X200 and TUS-X200S v3
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
Vantage Orian 1.5T MRT-1550, v4.5
Aquilion ONE (TSX-306A/3) V10 with Spectral Imaging System
XIDF-AWS801 Angio Workstation v5.31
Aquilion One Self Propelled Scan Base Kit
Infinix-CSi and Infinix DPi
Aplio A550 and A450 v2.8 Diagnostic Ultrasound System
Aquilion Exceed LB (TSX-202A/3) v10.9 with AiCE-i
Xario XG
XIDF-AWS801, Angio Workstation
Aquilion Prime Self Propelled Scan Base Kit for IVR-CT
INFX-8000V v6.20
Aquilion One (TSX-306A/3) v10.12 with Spectral Imaging, Vitrea Software Package, VSTP-001A
Aquilion Lightning (TSX-036A/7) v10.2 with AiCE-i
Vantage Titan MRT-1504/U5
Aquilion Prime TSX-303A/2 and A/3
Xario 200 Ultrasound Sylstem v5
Vitrea Software Package, VSTP-002A V2
Alphenix INFX-800H/B v8
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
Vantage Galan 3T MRT-3020 v7 SP0050* with AiCE Reconstruction Unit for MR
Aplio a550, Aplio a450, and Aplio a Diagnostic Ultrasound System, Software Version v6.5
MJAJ-197A
VTSP-001A MR Coronary Tracking
Aquilion Multi-Slice
Aplio i900/i800/i700/i600 v3.1 Diagnostic Ultrasound System
Aquilion ONE (TSX-308A/3) V1.5
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1
Aquilion One CT System w/4.7ER Software
Aquilion TSX-201A
Aplio 500/400/300 (v3)
Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
Octave Speeder Spine Coil MJAS-167A
Famio SSA-530
Cartesion Prime (PCD-1000A/3) V10.21
Vantage Galan 3T MRT-3020 v7 with AiCE Reconstruction Processing Unit for MR
Xario 200G and Xario 100G v1.1 Diagnostic Ultrasound System
Alphenix, INFX-8000V/B/S v9.1
Infinix-I, INFX-8000V v7
Aquilion Prime CT System TSX-302A/2
Aplio Artida SSH-880CV v3
Aplio Artida v2 SSH-880CV
Vantage Orian 1.5T MRT-1550 v6 with AiCE Reconstruction (AKA Compressed Speeder 2D up to 4X Acceleration
Alphenix INFX-8000f/B v8
Aplio 500/400/300 Diagnostic Ultrasound System
Aplio a550/a450/a Diagnostic Ultrasound System v4
UltraExtend, USWS-900A, v2.1 and 3.1
XIDF-AWS801 v7 Angio Workstation
Octave Speeder Head Coil MJAH-167A
Vantage Titan MRT-1510 v4
Vantage Fortian/Orian 1.5T, MRT-1550, V8 with AiCE Reconstruction Processing Unit for MR
Aquilion RXL TSX-101A/R
Vantage Galen 3T MRT-3020 v4.6
Cartesion Prime PCD-1000A
Vantage Galan 3T MRT-3020 V6
XIDF - AWS801, Angio Workstation (Alphenix Workstation) v8
Vantage Galan 3T, MRT-3020, V10 with AiCE Reconstruction Processing Unit for MR
Ultimax 1 FPD
INFX-8000V with 3DRM
Celestion PCA 9000A/2
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Vantage Galan 3T MRT-3020 v4
Vantage Fortian/Orian 1.5 T, MRT-1550, V8 with AiCE Reconstruction Processing Unit for MR
Infinix CFi & Infinix VFi
Aquioion One Vision TSX-301C/1 v4.90
Aquilion 32/64 SP TSX-101A/H, I
Aplio i900, Aplio i800 and Aplio i700 Software V7
Infinix V with 56 Inch Monitor
Vantage Titan 3T v2.30
Aplio i900/i800/i700/i600 v2.4 Diagnostic Ultrasound System
Aquilion Serve SP (TSX-307B) V2
Aquilion One Vision TSX-301C/1,/2,/3,/4,/5,/6./7,/8 v7
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7
Aquilion Serve (TSX-307A/1) V1.3
Celesteion PCA 9000A/3
Excelart Vantage Atlas
Vantage Orian 1.5T MRT-1550 v4.5
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
Vantage Galan 3T MRT-3020/A9, v5
Cartesion Prime (PCD-1000A/3) v10.8 with PET-AiCE
Aplio i900/i800/i700 Diagnostic Ultrasounnd System v2.1
Xario 100 TUS-X100 and TUS-X100X v3
Aquilion Serve SP (TSX-307B/1) V1.3
Aquilion Lightning TSX-036A/1 v8.4
Aquilion One Self-Propelled Scan Base Kit for IVR
Aquilion Prime
Vantage Orian 1.5T MRT-1550 v6 with AiCE Reconstruction Processing Unit for MR
UltraExtend NX CUW-U001S Ultrasound Image Analysis Program
Aquilion One TSX-306A/3 v10
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, v4
XIDF-AWS801 v6.10 Angio Workstation
Vantage Titan 3T MRT-3010/A5 v2.5
Aquilion One (TSX-306A/3) v10.4 with Spectral Imaging System
INFX-8000C v6.20
Vantage Titan
INFX-8000V, Wireless Foot Switch
PET-512MC Multiplane Transesophageal Transducer
Xario 200 Diagnostic Ultrasound System
Vantage Orian 1.5T, MRT-1550, v7 with AiCE Reconstruction Processing Unit for MR
MJAH-137A Atlas Speeder Coil
Vantage Galan 3T MRT-3020 v6 with AiCE Reconstruction Processing Unit for MR
Aquilion One TSX-305A/3 v7.3
Viamo c100 TUS-VC100 Diagnostic Ultrasound System
Aplio MX v1 SSA-780A
Aquilion Prime, v6
Vantage Orian 1.5T MRT-1550 v6
Nemio
Ultimax-i DREX-UI80 v1.60 (with TFP-1417W Wireless Detector)
Vantage Elan 1.5T MRT-2020 v6
Aplio 500/400/300 Diagnostic Ultrasound System, v5
INFX-8000H
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
Vantage Galan 3T, MRT-3020/A7 v5
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
Aquilion One TSX-301C v6
Vantage Titan MRT-1504/U4
Vitrea Software Toshiba Package VSTP-001A
Vantage Orian 1.5T MRT-1550 v6 with AiCE
Vantage Galan 3T MRT-3020 v6 with AiCE for MR (AKA AiCE body region expansion)
Vitrea Software Package VSTP-001
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
Cartesion Prime (PCD-1000A/3) V10.15
Aquilion Premium TSX-301B
Aquilion One TSX-301A
Aquilion One Vision with First 1 (CCRS-001A) TSX-301C/6,/7,/8 v 7.1
Titan 1.5T
Aquilion Prime SP TSX-303B/1, v8.4
Aquilion Precision TSX-304A/2 v8.6 with First 3
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility