510(k) Report

Devices descending from K994231

157 later devices reach Siemens Integrated Operating System (Sios) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+6K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+6K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+6K151904SyncVision SystemVolcano Corporation201521
+6K151485GenesisDornier Medtech America, Inc.20151—
+6K133434Genesis IIDornier Medtech America, Inc.20142—
+6K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+7K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+7K252503Intelligent NRCanon, Inc.20260—
+7K2434463DXRGE Medical Systems SCS20250—
+7K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+7K233543YSIO X.preeSiemens Medical Solutions20241—
+7K231995AcuityUDRRadmedix, LLC20230—
+7K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+7K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc.202244
+7K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+7K221335D²RS and D²RS 9090Stephanix20220—
+7K220871NautilusDornier Medtech America, Inc.20220—
+7K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+7K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+7K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+7K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+7K193326ARTIS IconoSiemens Medical Solutions USA, Inc.2020013
+7K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+7K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+7K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+7K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+7K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+7K161756SyncVision SystemVolcano Corporation201611
+8K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+8K251199Allia MoveoGE Medical Systems SCS202501
+8K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+8K250738YSIO X.preeSiemens Medical Solutions20250—
+8K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+8K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+8K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+8K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+8K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+8K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+8K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+8K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+8K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+8K172574SyncVision SystemVolcano Corporation201701
+9K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+9K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+9K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+9K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+9K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+10K251827Azurion R3.1Philips Medical Systems B.V.20251—
+10K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+10K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+10K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+11K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+11K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+11K254186Azurion R3.1Philips Medical Systems B.V.20260—
+11K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+11K233532MULTIX Impact ESiemens Medical Solutions20230—