510(k) Report

Devices descending from K010721

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K161756SyncVision SystemVolcano Corporation201611
+7K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation201592
+7K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation20147—
+8K251199Allia MoveoGE Medical Systems SCS202501
+8K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+8K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+8K250738YSIO X.preeSiemens Medical Solutions20250—
+8K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+8K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+8K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation202117
+8K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+8K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+8K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+8K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+8K172574SyncVision SystemVolcano Corporation201701
+8K152696Infx-8000V, V6.20Toshibamedical Systems Corporation201681
+8K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+9K251827Azurion R3.1Philips Medical Systems B.V.20251—
+9K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+9K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+9K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+9K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+9K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+9K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+10K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+10K254186Azurion R3.1Philips Medical Systems B.V.20260—
+10K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+10K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+10K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+10K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+10K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+10K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+10K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+11K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+11K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+11K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+11K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+11K233532MULTIX Impact ESiemens Medical Solutions20230—
+11K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation201841
+11K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+12K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+12K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation202032
+12K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+13K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+13K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+14K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation20251—
+14K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+15K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation20260—