510(k) Report

Devices descending from K970734

131 later devices reach Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992660Urf Digital - OTSiemens Medical Solutions USA, Inc.19991304
+2K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+2K051602Axiom Sireskop SDSiemens Medical Systems, Inc.200535
+2K040675Axiom Artis USiemens Medical Systems, Inc.2004491
+3K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+3K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+3K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+3K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+3K100371Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc.201116—
+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—
+3K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+3K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+3K070834CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc.20079—
+3K062647E-View Fluoroscopy System, Model CS-50Omega Medical Imaging, Inc.200610—
+3K051133Arcadis AvanticSiemens Medical Solutions USA, Inc.200520—
+4K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+4K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+4K223060DigiX FDXAllengers Medical Systems Limited20224—
+4K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+4K192541DigiX FDXAllengers Medical Systems Limited20195—
+4K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201914—
+4K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+4K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+4K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+4K162529DigiX FDXAllengers Medical Systems Limited20176—
+4K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc.2017101
+4K161019Uroview FDPausch Medical GmbH201621
+4K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+4K132094Cios AlphaSiemens Medi Cal Solutions, Inc.2014198
+4K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+4K122768GenesisDornier Medtech America, Inc.20134—
+4K121513Multix FusionSiemens Medical Solution2012324
+4K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+4K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+4K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+4K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+4K101042BladeviewAccogent, LLC20100—
+4K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+4K100102CS-Series-FPOmega Medical Imaging, Inc.20108—
+5K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+5K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+5K230985Planmeca VisoPlanmeca Oy20233—
+5K214097Explorer Air IISurgvision GmbH20222—
+5K213479D²RS and D²RS 9090Stephanix20211—
+5K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+5K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+5K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+5K203010Platinum dRF Imaging SystemApelem-Dms Group20210—
+5K200965XR-MX/1000Karl Storz Endoscopy America, Inc.20200—
+5K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+5K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+5K202235ArtPIX DRFCmt Medical Technologies, Ltd.20200—
+5K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+5K200887AS-10Canon, Inc.20200—
+5K192761Asimov-MKS Imaging SystemOnlume, Inc.20200—
+5K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20199—
+5K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+5K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+5K180651Uroview FD IIPausch Medical GmbH20180—
+5K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+5K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+5K153244Cios FusionSiemens Medical Solutions USA, Inc.2016151
+5K153147Cios ConnectSiemens Medical Solutions USA, Inc.20160—
+5K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+5K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+5K151485GenesisDornier Medtech America, Inc.20151—
+5K150663Diagnostic X-ray SystemOsko, Inc.20150—
+5K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+5K133434Genesis IIDornier Medtech America, Inc.20142—
+5K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+5K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+5K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC20127—
+6K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+6K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+6K252503Intelligent NRCanon, Inc.20260—
+6K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+6K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+6K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+6K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+6K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+6K223550DMXDel Medical, Inc.20230—
+6K222240Explorer Air® IISurgvision GmbH20231—
+6K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+6K221335D²RS and D²RS 9090Stephanix20220—
+6K220871NautilusDornier Medtech America, Inc.20220—
+6K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+6K200218Digiscan FDXAllengers Medical Systems Limited20201—
+6K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+6K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+6K183144uMC 560iShanghai United Imaging Healthcare Co., Ltd.20190—
+6K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC20194—
+6K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+6K181767Cios SelectSiemens Medical Solutions USA, Inc.20185—
+6K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+6K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC20181—
+6K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+6K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—