Company ยท JP
Canon Medical Systems Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
98510(k) clearances (6 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 31 |
| JAK | System, X-Ray, Tomography, Computed | 24 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 17 |
| OWB | Interventional Fluoroscopic X-Ray System | 12 |
| LLZ | System, Image Processing, Radiological | 7 |
| KPS | System, Tomography, Computed, Emission | 5 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 |
| QIH | Automated Radiological Image Processing Software | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 20, 2026 | K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 Canon Medical Systems Corporation, JP | JAK |
| Mar 27, 2026 | K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
| Mar 13, 2026 | K260078 | Aquilion ServeSP (TSX-307B) V2.0 Canon Medical Systems Corporation | JAK |
| Mar 10, 2026 | K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) Canon Medical Systems Corporation, JP | OWB |
| Jan 20, 2026 | K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System Canon Medical Systems Corporation, JP | IYN |
| Dec 1, 2025 | K251370 | Cartesion Prime (PCD-1000A/3) V10.21 Canon Medical Systems Corporation, JP | KPS |
| Oct 31, 2025 | K252074 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System Canon Medical Systems Corporation, JP | IYN |
| Oct 10, 2025 | K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging Canon Medical Systems Corporation, JP | OWB |
| Sep 26, 2025 | K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP Canon Medical Systems Corporation, JP | JAK |
| Jul 22, 2025 | K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
| Jun 20, 2025 | K243398 | CT Scanner TSX-501R/1 V11.1 Canon Medical Systems Corporation, JP | JAK |
| May 13, 2025 | K242808 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 Canon Medical Systems Corporation, JP | IYN |
| Apr 30, 2025 | K250328 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program Canon Medical Systems Corporation, JP | QIH |
| Jan 7, 2025 | K243335 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
| Dec 23, 2024 | K242403 | Aquilion ONE (TSX-308A/3) V1.5 Canon Medical Systems Corporation, JP | JAK |
| Sep 12, 2024 | K241582 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) Canon Medical Systems Corporation, JP | IYN |
| Aug 30, 2024 | K233107 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 Canon Medical Systems Corporation, JP | OWB |
| Aug 20, 2024 | K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
| Jul 17, 2024 | K240705 | Vitrea Software Package, VSTP-002A V2.0 Canon Medical Systems Corporation, JP | LLZ |
| Apr 12, 2024 | K240238 | Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
| Apr 2, 2024 | K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System Canon Medical Systems Corporation, JP | JAK |
| Jan 24, 2024 | K233195 | Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System Canon Medical Systems Corporation, JP | IYN |
| Dec 6, 2023 | K233334 | Aquilion Serve SP (TSX-307B/1) V1.3 Canon Medical Systems Corporation, JP | JAK |
| Nov 21, 2023 | K232988 | Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System Canon Medical Systems Corporation, JP | IYN |
| Sep 19, 2023 | K231281 | Aquilion Serve (TSX-307A/1) V1.3 Canon Medical Systems Corporation, JP | JAK |
| Sep 12, 2023 | K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 Canon Medical Systems Corporation, JP | JAA |
| Sep 12, 2023 | K231748 | Cartesion Prime (PCD-1000A/3) V10.15 Canon Medical Systems Corporation, JP | KPS |
| Aug 30, 2023 | K230355 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
| Mar 31, 2023 | K223017 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 Canon Medical Systems Corporation, JP | IYN |
| Mar 7, 2023 | K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE Canon Medical Systems Corporation, JP | JAK |
| Mar 3, 2023 | K222819 | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i Canon Medical Systems Corporation, JP | JAK |
| Jan 9, 2023 | K223336 | Vitrea Software Package, VSTP-002A Canon Medical Systems Corporation, JP | LLZ |
| Oct 25, 2022 | K222968 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
| Sep 27, 2022 | K220342 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 Canon Medical Systems Corporation, JP | OWB |
| Sep 12, 2022 | K220986 | Aquilion Precision (TSX-304A/4) V10.10 with AiCE Canon Medical Systems Corporation, JP | JAK |
| Aug 31, 2022 | K222387 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
| Jun 16, 2022 | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A Canon Medical Systems Corporation, JP | JAK |
| Apr 8, 2022 | K220192 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
| Apr 5, 2022 | K220335 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
| Mar 22, 2022 | K212960 | Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 Canon Medical Systems Corporation, JP | IYN |
| Mar 3, 2022 | K220018 | MR Elastography; MZEK-001A Canon Medical Systems Corporation, JP | LNH |
| Jan 24, 2022 | K212333 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 Canon Medical Systems Corporation, JP | IYN |
| Dec 1, 2021 | K213305 | Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
| Sep 10, 2021 | K211828 | Aquilion Exceed LB Canon Medical Systems Corporation, JP | JAK |
| Aug 4, 2021 | K212056 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
| Jul 22, 2021 | K211633 | Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
| May 17, 2021 | K211037 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
| Apr 23, 2021 | K203314 | Cartesion Prime (PCD-1000A/3) V10.8 Canon Medical Systems Corporation, JP | KPS |
| Apr 12, 2021 | K210900 | Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 Canon Medical Systems Corporation, JP | OWB |
| Apr 1, 2021 | K210340 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, JP | LNH |
Newest 50 of 98.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||