Company profile

Canon Medical Systems Corporation

Canon Medical Systems Corporation has 42 AI-enabled medical devices on the FDA list. The first decision was on June 12, 2019 and the most recent on May 20, 2026 (Aquilion ONE (TSX-308A/TSX-306A) V2.0). Its most common review panel is Radiology (42 devices).

42AI devices

2019First decision

2026Latest decision

1Specialties

Per year

20192020202120222023202420252026

Canon Medical Systems Corporation AI devices per year: 2019 2, 2020 5, 2021 7, 2022 5, 2023 7, 2024 6, 2025 6, 2026 4

By specialty

Radiology42

Timeline

May 20, 2026 · 510(k) K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0 · Radiology · JAK
March 27, 2026 · 510(k) K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR · Radiology · LNH
March 13, 2026 · 510(k) K260078Aquilion ServeSP (TSX-307B) V2.0 · Radiology · JAK
March 10, 2026 · 510(k) K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) · Radiology · OWB
December 1, 2025 · 510(k) K251370Cartesion Prime (PCD-1000A/3) V10.21 · Radiology · KPS
October 31, 2025 · 510(k) K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System · Radiology · IYN
October 10, 2025 · 510(k) K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging · Radiology · OWB
July 22, 2025 · 510(k) K250901Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR · Radiology · LNH
April 30, 2025 · 510(k) K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program · Radiology · QIH
January 7, 2025 · 510(k) K243335Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR · Radiology · LNH
December 23, 2024 · 510(k) K242403Aquilion ONE (TSX-308A/3) V1.5 · Radiology · JAK
September 12, 2024 · 510(k) K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) · Radiology · IYN
August 20, 2024 · 510(k) K241496Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR · Radiology · LNH
April 12, 2024 · 510(k) K240238Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR · Radiology · LNH
April 2, 2024 · 510(k) K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System · Radiology · JAK
January 24, 2024 · 510(k) K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System · Radiology · IYN
December 6, 2023 · 510(k) K233334Aquilion Serve SP (TSX-307B/1) V1.3 · Radiology · JAK
September 19, 2023 · 510(k) K231281Aquilion Serve (TSX-307A/1) V1.3 · Radiology · JAK
September 12, 2023 · 510(k) K231748Cartesion Prime (PCD-1000A/3) V10.15 · Radiology · KPS
September 12, 2023 · 510(k) K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 · Radiology · JAA
August 30, 2023 · 510(k) K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR · Radiology · LNH
March 7, 2023 · 510(k) K223726Aquilion Precision (TSX-304A/4) V10.14 with AiCE · Radiology · JAK
March 3, 2023 · 510(k) K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i · Radiology · JAK
September 12, 2022 · 510(k) K220986Aquilion Precision (TSX-304A/4) V10.10 with AiCE · Radiology · JAK
June 16, 2022 · 510(k) K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A · Radiology · JAK
April 8, 2022 · 510(k) K220192Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR · Radiology · LNH
March 22, 2022 · 510(k) K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 · Radiology · IYN
January 24, 2022 · 510(k) K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 · Radiology · IYN
December 1, 2021 · 510(k) K213305Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR · Radiology · LNH
September 10, 2021 · 510(k) K211828Aquilion Exceed LB · Radiology · JAK
April 23, 2021 · 510(k) K203314Cartesion Prime (PCD-1000A/3) V10.8 · Radiology · KPS
March 24, 2021 · 510(k) K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System · Radiology · JAK
March 4, 2021 · 510(k) K203323Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR · Radiology · LNH
January 15, 2021 · 510(k) K202767Vantage Orian 1.5T, MRT-1550, V6.0 · Radiology · LNH
January 12, 2021 · 510(k) K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i · Radiology · JAK
December 10, 2020 · 510(k) K203042Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I · Radiology · JAK
July 14, 2020 · 510(k) K193097Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR · Radiology · LNH
March 9, 2020 · 510(k) K192574Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR · Radiology · LNH
February 21, 2020 · 510(k) K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i · Radiology · JAK
February 13, 2020 · 510(k) K192828Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System · Radiology · JAK
July 5, 2019 · 510(k) K182901Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE · Radiology · JAK
June 12, 2019 · 510(k) K183046Aquilion ONE (TSX-305A/6) V8.9 with AiCE · Radiology · JAK