510(k) Report

Devices descending from K021021

218 later devices reach Modular Angiography System Axiom Artis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+9K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+9K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+10K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+10K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K233532MULTIX Impact ESiemens Medical Solutions20230—
+10K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation201841
+10K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation202032
+11K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+12K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+12K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+13K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation20251—
+13K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+14K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation20260—