Canon Medical Systems Corporation
Otawara-Shi, JP
Canon Medical Systems Corporation appears in FDA device records in Otawara-Shi, JP. FDA records list 97 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 97
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 97FDA records hold 97 510(k) clearances for Canon Medical Systems Corporation between 2018 and 2026. The busiest year on record is 2018, with 15. The most recent is 2026, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 15 |
| 2019 | 10 |
| 2020 | 15 |
| 2021 | 15 |
| 2022 | 10 |
| 2023 | 10 |
| 2024 | 8 |
| 2025 | 9 |
| 2026 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | JAK | Substantially Equivalent | |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent | |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | JAK | Substantially Equivalent | |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | OWB | Substantially Equivalent | |
| K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | KPS | Substantially Equivalent | |
| K252074 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | OWB | Substantially Equivalent | |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP | JAK | Substantially Equivalent | |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent | |
| K243398 | CT Scanner TSX-501R/1 V11.1 | JAK | Substantially Equivalent | |
| K242808 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 | IYN | Substantially Equivalent | |
| K250328 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program | QIH | Substantially Equivalent | |
| K243335 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent | |
| K242403 | Aquilion ONE (TSX-308A/3) V1.5 | JAK | Substantially Equivalent | |
| K241582 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) | IYN | Substantially Equivalent | |
| K233107 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 | OWB | Substantially Equivalent | |
| K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent | |
| K240705 | Vitrea Software Package, VSTP-002A V2.0 | LLZ | Substantially Equivalent | |
| K240238 | Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent | |
| K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | JAK | Substantially Equivalent | |
| K233195 | Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K233334 | Aquilion Serve SP (TSX-307B/1) V1.3 | JAK | Substantially Equivalent | |
| K232988 | Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K231281 | Aquilion Serve (TSX-307A/1) V1.3 | JAK | Substantially Equivalent | |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | JAA | Substantially Equivalent | |
| K231748 | Cartesion Prime (PCD-1000A/3) V10.15 | KPS | Substantially Equivalent | |
| K230355 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent | |
| K223017 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 | IYN | Substantially Equivalent | |
| K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE | JAK | Substantially Equivalent | |
| K222819 | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | JAK | Substantially Equivalent | |
| K223336 | Vitrea Software Package, VSTP-002A | LLZ | Substantially Equivalent | |
| K222968 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent | |
| K220342 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 | OWB | Substantially Equivalent | |
| K220986 | Aquilion Precision (TSX-304A/4) V10.10 with AiCE | JAK | Substantially Equivalent | |
| K222387 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent | |
| K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A | JAK | Substantially Equivalent | |
| K220192 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent | |
| K220335 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent | |
| K212960 | Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 | IYN | Substantially Equivalent | |
| K220018 | MR Elastography; MZEK-001A | LNH | Substantially Equivalent | |
| K212333 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | IYN | Substantially Equivalent | |
| K213305 | Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent | |
| K211828 | Aquilion Exceed LB | JAK | Substantially Equivalent | |
| K212056 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent | |
| K211633 | Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent | |
| K211037 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent | |
| K203314 | Cartesion Prime (PCD-1000A/3) V10.8 | KPS | Substantially Equivalent | |
| K210900 | Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 | OWB | Substantially Equivalent | |
| K210340 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR | LNH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- QIHAutomated Radiological Image Processing Software
- OWBInterventional Fluoroscopic X-Ray System
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- LNHSystem, Nuclear Magnetic Resonance Imaging
- KPSSystem, Tomography, Computed, Emission
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- JAKSystem, X-Ray, Tomography, Computed
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain