Canon Medical Systems Corporation

42 AI-enabled medical devices from Canon Medical Systems Corporation on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

DecisionNumberDeviceCompanyPanel
2026-05-20K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationRadiology
2026-03-27K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiology
2026-03-13K260078Aquilion ServeSP (TSX-307B) V2.0Canon Medical Systems CorporationRadiology
2026-03-10K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems CorporationRadiology
2025-12-01K251370Cartesion Prime (PCD-1000A/3) V10.21Canon Medical Systems CorporationRadiology
2025-10-31K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems CorporationRadiology
2025-10-10K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems CorporationRadiology
2025-07-22K250901Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiology
2025-04-30K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems CorporationRadiology
2025-01-07K243335Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiology
2024-12-23K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems CorporationRadiology
2024-09-12K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)Canon Medical Systems CorporationRadiology
2024-08-20K241496Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiology
2024-04-12K240238Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiology
2024-04-02K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems CorporationRadiology
2024-01-24K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems CorporationRadiology
2023-12-06K233334Aquilion Serve SP (TSX-307B/1) V1.3Canon Medical Systems CorporationRadiology
2023-09-19K231281Aquilion Serve (TSX-307A/1) V1.3Canon Medical Systems CorporationRadiology
2023-09-12K231748Cartesion Prime (PCD-1000A/3) V10.15Canon Medical Systems CorporationRadiology
2023-09-12K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems CorporationRadiology
2023-08-30K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiology
2023-03-07K223726Aquilion Precision (TSX-304A/4) V10.14 with AiCECanon Medical Systems CorporationRadiology
2023-03-03K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems CorporationRadiology
2022-09-12K220986Aquilion Precision (TSX-304A/4) V10.10 with AiCECanon Medical Systems CorporationRadiology
2022-06-16K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001ACanon Medical Systems CorporationRadiology
2022-04-08K220192Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiology
2022-03-22K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems CorporationRadiology
2022-01-24K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems CorporationRadiology
2021-12-01K213305Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiology
2021-09-10K211828Aquilion Exceed LBCanon Medical Systems CorporationRadiology
2021-04-23K203314Cartesion Prime (PCD-1000A/3) V10.8Canon Medical Systems CorporationRadiology
2021-03-24K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems CorporationRadiology
2021-03-04K203323Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiology
2021-01-15K202767Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems CorporationRadiology
2021-01-12K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems CorporationRadiology
2020-12-10K203042Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-ICanon Medical Systems CorporationRadiology
2020-07-14K193097Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiology
2020-03-09K192574Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiology
2020-02-21K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iCanon Medical Systems CorporationRadiology
2020-02-13K192828Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemCanon Medical Systems CorporationRadiology
2019-07-05K182901Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCECanon Medical Systems CorporationRadiology
2019-06-12K183046Aquilion ONE (TSX-305A/6) V8.9 with AiCECanon Medical Systems CorporationRadiology

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