FDA 510(k) Applications Submitted by Canon Medical Systems Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K230355 02/09/2023 Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K222387 08/08/2022 Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K222968 09/27/2022 Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K203553 12/04/2020 Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K210164 01/21/2021 Vantage Elan 1.5T, MRT-2020, V6.0 Canon Medical Systems Corporation
K211633 05/27/2021 Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K212056 07/01/2021 Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K213305 10/04/2021 Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K203323 11/12/2020 Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K220018 01/05/2022 MR Elastography; MZEK-001A Canon Medical Systems Corporation
K220192 01/24/2022 Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K180323 02/05/2018 Vitrea Software Package; VSTP-001A Canon Medical Systems Corporation
K210340 02/05/2021 Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K220335 02/07/2022 Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K220342 02/07/2022 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 Canon Medical Systems Corporation
K190505 03/01/2019 Low Dose Lung Screening Option Canon Medical Systems Corporation
K210900 03/26/2021 Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 Canon Medical Systems Corporation
K220986 04/04/2022 Aquilion Precision (TSX-304A/4) V10.10 with AiCE Canon Medical Systems Corporation
K211037 04/07/2021 Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K191128 04/29/2019 Vantage Titan 3T, MRT-3010, V2.5 Canon Medical Systems Corporation
K231281 05/03/2023 Aquilion Serve (TSX-307A/1) V1.3 Canon Medical Systems Corporation
K181415 05/30/2018 XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 Canon Medical Systems Corporation
K191467 06/03/2019 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 Canon Medical Systems Corporation
K191582 06/14/2019 Cartesion Prime Canon Medical Systems Corporation
K211828 06/14/2021 Aquilion Exceed LB Canon Medical Systems Corporation
K231748 06/15/2023 Cartesion Prime (PCD-1000A/3) V10.15 Canon Medical Systems Corporation
K181593 06/18/2018 Vantage Galan 3T, MRT-3020/A7, V5.0 Canon Medical Systems Corporation
K191662 06/21/2019 Vantage Orian 1.5T, MRT-1550, V4.5 Canon Medical Systems Corporation
K191663 06/21/2019 Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 Canon Medical Systems Corporation
K181646 06/22/2018 Celesteion, PCA-9000A/3, V6.5 Canon Medical Systems Corporation
K181670 06/25/2018 Alphenix, INFX-8000V/B, V8.0 Canon Medical Systems Corporation
K201836 07/02/2020 Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i Canon Medical Systems Corporation
K181804 07/06/2018 Alphenix, INFX-8000C/B, V8.0 Canon Medical Systems Corporation
K181834 07/10/2018 Ultimax-i, DREX-UI80 (V1.60) Canon Medical Systems Corporation
K201972 07/15/2020 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 Canon Medical Systems Corporation
K212333 07/27/2021 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 Canon Medical Systems Corporation
K202210 08/06/2020 Vantage Orian 1.5T, MRT-1550, V6.0 Canon Medical Systems Corporation
K192188 08/13/2019 Aquilion ONE (TSX-306A/3) V10.0 Canon Medical Systems Corporation
K202349 08/18/2020 Cartesion Prime, PCD-1000A, V10.7 Canon Medical Systems Corporation
K202364 08/19/2020 Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 Canon Medical Systems Corporation
K232526 08/21/2023 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 Canon Medical Systems Corporation
K182282 08/23/2018 Vantage Orian 1.5T, MRT-1550, V4.5 Canon Medical Systems Corporation
K182415 09/04/2018 Alphenix, INFX-8000F/B, V8.0 Canon Medical Systems Corporation
K182427 09/06/2018 Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System Canon Medical Systems Corporation
K192506 09/12/2019 Vantage Galan 3T, MRT-3020, V6.0 Canon Medical Systems Corporation
K212960 09/16/2021 Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 Canon Medical Systems Corporation
K182546 09/17/2018 Alphenix, INFX-8000H/B, V8.0 Canon Medical Systems Corporation
K202737 09/18/2020 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System Canon Medical Systems Corporation
K192574 09/19/2019 Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K222819 09/19/2022 Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i Canon Medical Systems Corporation
K182596 09/20/2018 Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System Canon Medical Systems Corporation
K182601 09/21/2018 Vitrea Software Package, VSTP-001A Canon Medical Systems Corporation
K202767 09/21/2020 Vantage Orian 1.5T, MRT-1550, V6.0 Canon Medical Systems Corporation
K182679 09/26/2018 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 Canon Medical Systems Corporation
K223017 09/29/2022 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 Canon Medical Systems Corporation
K192832 10/02/2019 Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i Canon Medical Systems Corporation
K192828 10/02/2019 Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System Canon Medical Systems Corporation
K203042 10/06/2020 Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I Canon Medical Systems Corporation
K203053 10/07/2020 Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K182901 10/16/2018 Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE Canon Medical Systems Corporation
K192923 10/16/2019 Vitrea Software Package Canon Medical Systems Corporation
K193021 10/30/2019 Vantage Orian 1.5T, MRT-1550, V6.0 Canon Medical Systems Corporation
K183013 10/31/2018 Vitrea Software Package, VSTP-001A Canon Medical Systems Corporation
K213504 11/01/2021 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A Canon Medical Systems Corporation
K223336 11/01/2022 Vitrea Software Package, VSTP-002A Canon Medical Systems Corporation
K183046 11/02/2018 Aquilion ONE (TSX-305A/6) V8.9 with AiCE Canon Medical Systems Corporation
K203225 11/02/2020 Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System Canon Medical Systems Corporation
K193097 11/07/2019 Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K203312 11/10/2020 Vitrea Software Package, VSTP-001A Canon Medical Systems Corporation
K203314 11/10/2020 Cartesion Prime (PCD-1000A/3) V10.8 Canon Medical Systems Corporation
K203551 12/04/2020 Alphenix, INFX-8000V/B, /S, V9.1 Canon Medical Systems Corporation
K223726 12/13/2022 Aquilion Precision (TSX-304A/4) V10.14 with AiCE Canon Medical Systems Corporation
K183657 12/27/2018 Vantage Galan 3T, MRT-3020/A9, V5.0 Canon Medical Systems Corporation


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