Canon Medical Systems Corporation
42 AI-enabled device listings under this company name on the FDA list. The name is copied as published. It is not a review of the company.
| Date | Submission | Device | Panel | Code |
|---|---|---|---|---|
| May 20, 2026 | K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Radiology | JAK |
| March 27, 2026 | K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Radiology | LNH |
| March 13, 2026 | K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Radiology | JAK |
| March 10, 2026 | K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Radiology | OWB |
| December 1, 2025 | K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | Radiology | KPS |
| October 31, 2025 | K252074 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System | Radiology | IYN |
| October 10, 2025 | K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | Radiology | OWB |
| July 22, 2025 | K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Radiology | LNH |
| April 30, 2025 | K250328 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program | Radiology | QIH |
| January 7, 2025 | K243335 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | Radiology | LNH |
| December 23, 2024 | K242403 | Aquilion ONE (TSX-308A/3) V1.5 | Radiology | JAK |
| September 12, 2024 | K241582 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) | Radiology | IYN |
| August 20, 2024 | K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | Radiology | LNH |
| April 12, 2024 | K240238 | Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR | Radiology | LNH |
| April 2, 2024 | K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Radiology | JAK |
| January 24, 2024 | K233195 | Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System | Radiology | IYN |
| December 6, 2023 | K233334 | Aquilion Serve SP (TSX-307B/1) V1.3 | Radiology | JAK |
| September 19, 2023 | K231281 | Aquilion Serve (TSX-307A/1) V1.3 | Radiology | JAK |
| September 12, 2023 | K231748 | Cartesion Prime (PCD-1000A/3) V10.15 | Radiology | KPS |
| September 12, 2023 | K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Radiology | JAA |
| August 30, 2023 | K230355 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR | Radiology | LNH |
| March 7, 2023 | K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE | Radiology | JAK |
| March 3, 2023 | K222819 | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | Radiology | JAK |
| September 12, 2022 | K220986 | Aquilion Precision (TSX-304A/4) V10.10 with AiCE | Radiology | JAK |
| June 16, 2022 | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A | Radiology | JAK |
| April 8, 2022 | K220192 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR | Radiology | LNH |
| March 22, 2022 | K212960 | Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 | Radiology | IYN |
| January 24, 2022 | K212333 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | Radiology | IYN |
| December 1, 2021 | K213305 | Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR | Radiology | LNH |
| September 10, 2021 | K211828 | Aquilion Exceed LB | Radiology | JAK |
| April 23, 2021 | K203314 | Cartesion Prime (PCD-1000A/3) V10.8 | Radiology | KPS |
| March 24, 2021 | K203225 | Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System | Radiology | JAK |
| March 4, 2021 | K203323 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Radiology | LNH |
| January 15, 2021 | K202767 | Vantage Orian 1.5T, MRT-1550, V6.0 | Radiology | LNH |
| January 12, 2021 | K201836 | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i | Radiology | JAK |
| December 10, 2020 | K203042 | Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I | Radiology | JAK |
| July 14, 2020 | K193097 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR | Radiology | LNH |
| March 9, 2020 | K192574 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Radiology | LNH |
| February 21, 2020 | K192832 | Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i | Radiology | JAK |
| February 13, 2020 | K192828 | Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System | Radiology | JAK |
| July 5, 2019 | K182901 | Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE | Radiology | JAK |
| June 12, 2019 | K183046 | Aquilion ONE (TSX-305A/6) V8.9 with AiCE | Radiology | JAK |