510(k) Report

Devices descending from K121513

32 later devices reach Multix Fusion through their predicates, nearest generation first.

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