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Canon Medical Systems Corporation

FDA 510(k) & PMA Approved Devices — 97 products

Total Devices97
Categories8
Latest FDA decision2026-05-20
TypeNumberDevice NameCodeDateActions
510(k) K220018 MR Elastography; MZEK-001ALNH2022-03-03 View
510(k) K212333 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5IYN2022-01-24 View
510(k) K213305 Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2021-12-01 View
510(k) K211828 Aquilion Exceed LBJAK2021-09-10 View
510(k) K212056 Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-08-04 View
510(k) K211633 Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-07-22 View
510(k) K211037 Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-05-17 View
510(k) K203314 Cartesion Prime (PCD-1000A/3) V10.8KPS2021-04-23 View
510(k) K210900 Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2OWB2021-04-12 View
510(k) K210340 Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-04-01 View
510(k) K203225 Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemJAK2021-03-24 View
510(k) K210164 Vantage Elan 1.5T, MRT-2020, V6.0LNH2021-03-10 View
510(k) K203323 Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH2021-03-04 View
510(k) K203312 Vitrea Software Package, VSTP-001ALLZ2021-02-16 View
510(k) K203553 Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2021-02-02 View
510(k) K202767 Vantage Orian 1.5T, MRT-1550, V6.0LNH2021-01-15 View
510(k) K201836 Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iJAK2021-01-12 View
510(k) K203551 Alphenix, INFX-8000V/B, /S, V9.1OWB2020-12-18 View
510(k) K203042 Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-IJAK2020-12-10 View
510(k) K203053 Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRLNH2020-12-02 View

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