510(k) Report

Devices descending from K081722

43 later devices reach YSIO through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223060DigiX FDXAllengers Medical Systems Limited20224—
+1K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+1K192541DigiX FDXAllengers Medical Systems Limited20195—
+1K162529DigiX FDXAllengers Medical Systems Limited20176—
+1K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+1K121513Multix FusionSiemens Medical Solution2012324
+1K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+2K230985Planmeca VisoPlanmeca Oy20233—
+2K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+2K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+2K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+2K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+2K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+2K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+2K150663Diagnostic X-ray SystemOsko, Inc.20150—
+2K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+2K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+3K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+3K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+3K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+3K223550DMXDel Medical, Inc.20230—
+3K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+3K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+3K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+3K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+3K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+3K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+4K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+4K233543YSIO X.preeSiemens Medical Solutions20241—
+4K231995AcuityUDRRadmedix, LLC20230—
+4K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+4K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+4K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+5K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+5K250738YSIO X.preeSiemens Medical Solutions20250—
+5K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+6K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+6K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+7K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+7K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+8K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+8K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+8K233532MULTIX Impact ESiemens Medical Solutions20230—