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42 devices · 1 company · 2019 to 2026

Canon Medical Systems Corporation: AI-enabled devices on FDA's list

42 devices from Canon Medical Systems Corporation, 2019 to 2026, from 1 company across 7 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (42 of 42 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes from Canon Medical Systems Corporation

Every device, newest decision first

Canon Medical Systems Corporation · 42 devices
DecisionDevicePanelProduct codeFDA
Aquilion ONEK253596 · 510(k)RadiologyJAKdatabase entry
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 withK253625 · 510(k)RadiologyLNHdatabase entry
Aquilion ServeSPK260078 · 510(k)RadiologyJAKdatabase entry
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 withK253584 · 510(k)RadiologyOWBdatabase entry
Cartesion PrimeK251370 · 510(k)RadiologyKPSdatabase entry
Aplio i900, Aplio i800 and Aplio i700 Software VK252074 · 510(k)RadiologyIYNdatabase entry
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 withK251602 · 510(k)RadiologyOWBdatabase entry
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 withK250901 · 510(k)RadiologyLNHdatabase entry
UltraExtend NX CUW-U001S V2.0 Ultrasound Image AK250328 · 510(k)RadiologyQIHdatabase entry
Vantage Galan 3T, MRT-3020, V10.0 with AiCE RecoK243335 · 510(k)RadiologyLNHdatabase entry
Aquilion ONEK242403 · 510(k)RadiologyJAKdatabase entry
Aplio i900/i800/i700 Diagnostic Ultrasound SysteK241582 · 510(k)RadiologyIYNdatabase entry
Vantage Galan 3T, MRT-3020, V10.0 with AiCE RecoK241496 · 510(k)RadiologyLNHdatabase entry
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 withK240238 · 510(k)RadiologyLNHdatabase entry
Aquilion ONEK232835 · 510(k)RadiologyJAKdatabase entry
Aplio i900, Aplio i800 and Aplio i700 Software VK233195 · 510(k)RadiologyIYNdatabase entry
Aquilion Serve SPK233334 · 510(k)RadiologyJAKdatabase entry
Aquilion ServeK231281 · 510(k)RadiologyJAKdatabase entry
Cartesion PrimeK231748 · 510(k)RadiologyKPSdatabase entry
XIDF-AWS801, Angio WorkstationK232526 · 510(k)RadiologyJAAdatabase entry
Vantage Galan 3T, MRT-3020, V9.0 with AiCE ReconK230355 · 510(k)RadiologyLNHdatabase entry
Aquilion PrecisionK223726 · 510(k)RadiologyJAKdatabase entry
Aquilion ServeK222819 · 510(k)RadiologyJAKdatabase entry
Aquilion PrecisionK220986 · 510(k)RadiologyJAKdatabase entry
Aquilion ONEK213504 · 510(k)RadiologyJAKdatabase entry
Vantage Galan 3T, MRT-3020, V8.0 with AiCE ReconK220192 · 510(k)RadiologyLNHdatabase entry
Aplio a550, Aplio a450, and Aplio a, DiagnosticK212960 · 510(k)RadiologyIYNdatabase entry
Aplio i900/i800/i700 Diagnostic Ultrasound SysteK212333 · 510(k)RadiologyIYNdatabase entry
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE RK213305 · 510(k)RadiologyLNHdatabase entry
Aquilion Exceed LBK211828 · 510(k)RadiologyJAKdatabase entry
Cartesion PrimeK203314 · 510(k)RadiologyKPSdatabase entry
Aquilion ONEK203225 · 510(k)RadiologyJAKdatabase entry
Vantage Galan 3T, MRT-3020, V6.0 with AiCE ReconK203323 · 510(k)RadiologyLNHdatabase entry
Vantage Orian 1.5T, MRT-1550, V6.0K202767 · 510(k)RadiologyLNHdatabase entry
Aquilion LightningK201836 · 510(k)RadiologyJAKdatabase entry
Aquilion Exceed LBK203042 · 510(k)RadiologyJAKdatabase entry
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE RecK193097 · 510(k)RadiologyLNHdatabase entry
Vantage Galan 3T, MRT-3020, V6.0 with AiCE ReconK192574 · 510(k)RadiologyLNHdatabase entry
Aquilion Prime SPK192832 · 510(k)RadiologyJAKdatabase entry
Aquilion ONEK192828 · 510(k)RadiologyJAKdatabase entry
Aquilion PrecisionK182901 · 510(k)RadiologyJAKdatabase entry
Aquilion ONEK183046 · 510(k)RadiologyJAKdatabase entry

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