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Canon Medical Systems Corporation

FDA 510(k) & PMA Approved Devices — 96 products

Total Devices96
Categories8
Latest Approval2026-03-27
TypeNumberDevice NameCodeDate
510(k) K253625 Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR LNH 2026-03-27 View
510(k) K260078 Aquilion ServeSP (TSX-307B) V2.0 JAK 2026-03-13 View
510(k) K253584 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) OWB 2026-03-10 View
510(k) K253597 Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System IYN 2026-01-20 View
510(k) K251370 Cartesion Prime (PCD-1000A/3) V10.21 KPS 2025-12-01 View
510(k) K252074 Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System IYN 2025-10-31 View
510(k) K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging OWB 2025-10-10 View
510(k) K251645 Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP JAK 2025-09-26 View
510(k) K250901 Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR LNH 2025-07-22 View
510(k) K243398 CT Scanner TSX-501R/1 V11.1 JAK 2025-06-20 View
510(k) K242808 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 IYN 2025-05-13 View
510(k) K250328 UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program QIH 2025-04-30 View
510(k) K243335 Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR LNH 2025-01-07 View
510(k) K242403 Aquilion ONE (TSX-308A/3) V1.5 JAK 2024-12-23 View
510(k) K241582 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) IYN 2024-09-12 View
510(k) K233107 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 OWB 2024-08-30 View
510(k) K241496 Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR LNH 2024-08-20 View
510(k) K240705 Vitrea Software Package, VSTP-002A V2.0 LLZ 2024-07-17 View
510(k) K240238 Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR LNH 2024-04-12 View
510(k) K232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System JAK 2024-04-02 View
510(k) K233195 Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System IYN 2024-01-24 View
510(k) K233334 Aquilion Serve SP (TSX-307B/1) V1.3 JAK 2023-12-06 View
510(k) K232988 Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System IYN 2023-11-21 View
510(k) K231281 Aquilion Serve (TSX-307A/1) V1.3 JAK 2023-09-19 View
510(k) K231748 Cartesion Prime (PCD-1000A/3) V10.15 KPS 2023-09-12 View
510(k) K232526 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 JAA 2023-09-12 View
510(k) K230355 Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR LNH 2023-08-30 View
510(k) K223017 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 IYN 2023-03-31 View
510(k) K223726 Aquilion Precision (TSX-304A/4) V10.14 with AiCE JAK 2023-03-07 View
510(k) K222819 Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i JAK 2023-03-03 View
510(k) K223336 Vitrea Software Package, VSTP-002A LLZ 2023-01-09 View
510(k) K222968 Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR LNH 2022-10-25 View
510(k) K220342 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 OWB 2022-09-27 View
510(k) K220986 Aquilion Precision (TSX-304A/4) V10.10 with AiCE JAK 2022-09-12 View
510(k) K222387 Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR LNH 2022-08-31 View
510(k) K213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A JAK 2022-06-16 View
510(k) K220192 Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR LNH 2022-04-08 View
510(k) K220335 Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR LNH 2022-04-05 View
510(k) K212960 Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 IYN 2022-03-22 View
510(k) K220018 MR Elastography; MZEK-001A LNH 2022-03-03 View
510(k) K212333 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 IYN 2022-01-24 View
510(k) K213305 Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR LNH 2021-12-01 View
510(k) K211828 Aquilion Exceed LB JAK 2021-09-10 View
510(k) K212056 Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR LNH 2021-08-04 View
510(k) K211633 Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR LNH 2021-07-22 View
510(k) K211037 Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR LNH 2021-05-17 View
510(k) K203314 Cartesion Prime (PCD-1000A/3) V10.8 KPS 2021-04-23 View
510(k) K210900 Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 OWB 2021-04-12 View
510(k) K210340 Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR LNH 2021-04-01 View
510(k) K203225 Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System JAK 2021-03-24 View
510(k) K210164 Vantage Elan 1.5T, MRT-2020, V6.0 LNH 2021-03-10 View
510(k) K203323 Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR LNH 2021-03-04 View
510(k) K203312 Vitrea Software Package, VSTP-001A LLZ 2021-02-16 View
510(k) K203553 Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR LNH 2021-02-02 View
510(k) K202767 Vantage Orian 1.5T, MRT-1550, V6.0 LNH 2021-01-15 View
510(k) K201836 Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i JAK 2021-01-12 View
510(k) K203551 Alphenix, INFX-8000V/B, /S, V9.1 OWB 2020-12-18 View
510(k) K203042 Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I JAK 2020-12-10 View
510(k) K203053 Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR LNH 2020-12-02 View
510(k) K202737 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System IYN 2020-10-16 View
510(k) K202364 Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 IYN 2020-10-15 View
510(k) K202349 Cartesion Prime, PCD-1000A, V10.7 KPS 2020-10-15 View
510(k) K201972 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 IYN 2020-10-08 View
510(k) K202210 Vantage Orian 1.5T, MRT-1550, V6.0 LNH 2020-09-22 View
510(k) K193097 Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR LNH 2020-07-14 View
510(k) K193021 Vantage Orian 1.5T, MRT-1550, V6.0 LNH 2020-06-03 View
510(k) K192574 Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR LNH 2020-03-09 View
510(k) K192506 Vantage Galan 3T, MRT-3020, V6.0 LNH 2020-03-02 View
510(k) K192832 Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i JAK 2020-02-21 View
510(k) K192923 Vitrea Software Package LLZ 2020-02-14 View
510(k) K192828 Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System JAK 2020-02-13 View
510(k) K191663 Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 IYN 2019-09-18 View
510(k) K192188 Aquilion ONE (TSX-306A/3) V10.0 JAK 2019-09-06 View
510(k) K191582 Cartesion Prime KPS 2019-08-13 View
510(k) K191662 Vantage Orian 1.5T, MRT-1550, V4.5 LNH 2019-07-23 View
510(k) K191467 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 IYN 2019-07-19 View
510(k) K182901 Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE JAK 2019-07-05 View
510(k) K191128 Vantage Titan 3T, MRT-3010, V2.5 LNH 2019-06-26 View
510(k) K183046 Aquilion ONE (TSX-305A/6) V8.9 with AiCE JAK 2019-06-12 View
510(k) K190505 Low Dose Lung Screening Option JAK 2019-06-05 View
510(k) K183657 Vantage Galan 3T, MRT-3020/A9, V5.0 LNH 2019-03-15 View
510(k) K182601 Vitrea Software Package, VSTP-001A LLZ 2018-12-14 View
510(k) K183013 Vitrea Software Package, VSTP-001A LLZ 2018-11-26 View
510(k) K181646 Celesteion, PCA-9000A/3, V6.5 JAK 2018-11-16 View
510(k) K182596 Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System IYN 2018-11-02 View
510(k) K182427 Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System IYN 2018-11-02 View
510(k) K182679 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 IYN 2018-10-31 View
510(k) K182282 Vantage Orian 1.5T, MRT-1550, V4.5 LNH 2018-10-19 View
510(k) K182546 Alphenix, INFX-8000H/B, V8.0 OWB 2018-10-17 View
510(k) K182415 Alphenix, INFX-8000F/B, V8.0 OWB 2018-09-28 View
510(k) K181415 XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 OWB 2018-09-10 View
510(k) K181593 Vantage Galan 3T, MRT-3020/A7, V5.0 LNH 2018-08-13 View
510(k) K181804 Alphenix, INFX-8000C/B, V8.0 OWB 2018-08-02 View
510(k) K181670 Alphenix, INFX-8000V/B, V8.0 OWB 2018-07-25 View
510(k) K181834 Ultimax-i, DREX-UI80 (V1.60) OWB 2018-07-19 View
510(k) K180323 Vitrea Software Package; VSTP-001A LLZ 2018-03-30 View
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