510(k) Report

Devices descending from K013826

81 later devices reach Axiom Aristos FX (Multi Purpose Radiography System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc.2006803
+2K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+2K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+2K080614DR Vision Neo, DR Vision DouAlmana Medical Imaging20080—
+2K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+3K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+3K223060DigiX FDXAllengers Medical Systems Limited20224—
+3K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+3K192541DigiX FDXAllengers Medical Systems Limited20195—
+3K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+3K162529DigiX FDXAllengers Medical Systems Limited20176—
+3K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+3K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+3K121513Multix FusionSiemens Medical Solution2012324
+3K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+3K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+3K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+3K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+3K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+3K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+3K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+4K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+4K230985Planmeca VisoPlanmeca Oy20233—
+4K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+4K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+4K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+4K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+4K161019Uroview FDPausch Medical GmbH201621
+4K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+4K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+4K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+4K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+4K150663Diagnostic X-ray SystemOsko, Inc.20150—
+4K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+4K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+4K122768GenesisDornier Medtech America, Inc.20134—
+4K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+4K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+4K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+4K101042BladeviewAccogent, LLC20100—
+4K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+5K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+5K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+5K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+5K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+5K223550DMXDel Medical, Inc.20230—
+5K213479D²RS and D²RS 9090Stephanix20211—
+5K203010Platinum dRF Imaging SystemApelem-Dms Group20210—
+5K200965XR-MX/1000Karl Storz Endoscopy America, Inc.20200—
+5K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+5K202235ArtPIX DRFCmt Medical Technologies, Ltd.20200—
+5K200887AS-10Canon, Inc.20200—
+5K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+5K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+5K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+5K180651Uroview FD IIPausch Medical GmbH20180—
+5K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+5K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+5K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+5K151485GenesisDornier Medtech America, Inc.20151—
+5K133434Genesis IIDornier Medtech America, Inc.20142—
+5K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+6K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+6K252503Intelligent NRCanon, Inc.20260—
+6K233543YSIO X.preeSiemens Medical Solutions20241—
+6K231995AcuityUDRRadmedix, LLC20230—
+6K221335D²RS and D²RS 9090Stephanix20220—
+6K220871NautilusDornier Medtech America, Inc.20220—
+6K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+6K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+6K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+7K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+7K250738YSIO X.preeSiemens Medical Solutions20250—
+7K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+8K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+8K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+9K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+9K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+10K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+10K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+10K233532MULTIX Impact ESiemens Medical Solutions20230—