510(k) Report

Devices descending from K911904

231 later devices reach Models Ues-10 & PSD-10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+10K161756SyncVision SystemVolcano Corporation201611
+11K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+11K251199Allia MoveoGE Medical Systems SCS202501
+11K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+11K250738YSIO X.preeSiemens Medical Solutions20250—
+11K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+11K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+11K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+11K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+11K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+11K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+11K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+11K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+11K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+11K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+11K172574SyncVision SystemVolcano Corporation201701
+12K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+12K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+12K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+12K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+12K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+13K251827Azurion R3.1Philips Medical Systems B.V.20251—
+13K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+13K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+13K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+14K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+14K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+14K254186Azurion R3.1Philips Medical Systems B.V.20260—
+14K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+14K233532MULTIX Impact ESiemens Medical Solutions20230—