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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) K232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemJAK2024-04-02 View
510(k) K233195 Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemIYN2024-01-24 View
510(k) K233334 Aquilion Serve SP (TSX-307B/1) V1.3JAK2023-12-06 View
510(k) K232988 Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemIYN2023-11-21 View
510(k) K231281 Aquilion Serve (TSX-307A/1) V1.3JAK2023-09-19 View
510(k) K231748 Cartesion Prime (PCD-1000A/3) V10.15KPS2023-09-12 View
510(k) K232526 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA2023-09-12 View
510(k) K230355 Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRLNH2023-08-30 View
510(k) K223017 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0IYN2023-03-31 View
510(k) K223726 Aquilion Precision (TSX-304A/4) V10.14 with AiCEJAK2023-03-07 View
510(k) K222819 Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iJAK2023-03-03 View
510(k) K223336 Vitrea Software Package, VSTP-002ALLZ2023-01-09 View
510(k) K222968 Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2022-10-25 View
510(k) K220342 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3OWB2022-09-27 View
510(k) K220986 Aquilion Precision (TSX-304A/4) V10.10 with AiCEJAK2022-09-12 View
510(k) K222387 Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2022-08-31 View
510(k) K213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001AJAK2022-06-16 View
510(k) K220192 Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2022-04-08 View
510(k) K220335 Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRLNH2022-04-05 View
510(k) K212960 Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5IYN2022-03-22 View

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