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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) K190505 Low Dose Lung Screening OptionJAK2019-06-05 View
510(k) K183657 Vantage Galan 3T, MRT-3020/A9, V5.0LNH2019-03-15 View
510(k) K182601 Vitrea Software Package, VSTP-001ALLZ2018-12-14 View
510(k) K183013 Vitrea Software Package, VSTP-001ALLZ2018-11-26 View
510(k) K181646 Celesteion, PCA-9000A/3, V6.5JAK2018-11-16 View
510(k) K182596 Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemIYN2018-11-02 View
510(k) K182427 Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemIYN2018-11-02 View
510(k) K182679 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1IYN2018-10-31 View
510(k) K182282 Vantage Orian 1.5T, MRT-1550, V4.5LNH2018-10-19 View
510(k) K182546 Alphenix, INFX-8000H/B, V8.0OWB2018-10-17 View
510(k) K182415 Alphenix, INFX-8000F/B, V8.0OWB2018-09-28 View
510(k) K181415 XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0OWB2018-09-10 View
510(k) K181593 Vantage Galan 3T, MRT-3020/A7, V5.0LNH2018-08-13 View
510(k) K181804 Alphenix, INFX-8000C/B, V8.0OWB2018-08-02 View
510(k) K181670 Alphenix, INFX-8000V/B, V8.0OWB2018-07-25 View
510(k) K181834 Ultimax-i, DREX-UI80 (V1.60)OWB2018-07-19 View
510(k) K180323 Vitrea Software Package; VSTP-001ALLZ2018-03-30 View

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