510(k) Report

Devices descending from K993037

330 later devices reach LCV+ Version 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100102CS-Series-FPOmega Medical Imaging, Inc.20108—
+1K050489Innova 2100Ge Medical Systems, LLC20057527
+1K023178Innova 4100Ge Medical Systems, Inc.20029725
+1K022322Innova and Innova 2000 SGe Medical Systems, Inc.2002787
+1K021021Modular Angiography System Axiom ArtisSiemens Medical Solutions USA, Inc.200221821
+1K020055Philips Integris Allura 9 with FD OptionPhilips Medical Systems20021242
+2K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC20127—
+2K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+2K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+2K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+2K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+2K091658GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100…GE Healthcare2009111
+2K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc.20087239
+2K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+2K063628Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions2006183
+2K061163Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Ge Medical Systems, LLC20062238
+2K060259Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC2006474
+2K052412Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQGE Healthcare20057450
+2K041780New BridMedical Imaging Solutions, Inc.20040—
+2K033244Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table OptionGe Medical Systems, Inc.2003758
+2K031637Innova 3100GE Medical Systems20037625
+2K024200Innova 2000 and Innova 2000S (Mobile Version)Ge Medical Systems, Inc.200307
+2K022899Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co.20021148
+3K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC20194—
+3K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+3K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC20181—
+3K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+3K152352Stereo 3D option for Vision ApplicationsGE Medical Systems SCS20161—
+3K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+3K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+3K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+3K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+3K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+3K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+3K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+3K112720Mckesson Horizon CardiologyMckesson Israel, Ltd.20123—
+3K111209Integrated Innova - S5I System OptionGE Healthcare201182
+3K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+3K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+3K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+3K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+3K091166IMRXImris, Inc.20091—
+3K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+3K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+3K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+3K081630Mammo WorkstationImage Diagnost International GmbH20084—
+3K081624Infx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C2008138
+3K081621Infx-8000C (Infinix CC-I and VC-I)Toshiba America Medical Systems, In.C2008101
+3K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C2008231
+3K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+3K081018Syngo Dynamics Version 7.0Siemens Medical Solutions20088—
+3K031333Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc.200311325
+4K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+4K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+4K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+4K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS20220—
+4K223060DigiX FDXAllengers Medical Systems Limited20224—
+4K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+4K213479D²RS and D²RS 9090Stephanix20211—
+4K212890Nyquist.IQOmega Medical Imaging, LLC20210—
+4K212336Soteria.AIOmega Medical Imaging, LLC20211—
+4K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+4K201172CFP-3131, CFP-2222Mx Imaging, Inc.20200—
+4K200887AS-10Canon, Inc.20200—
+4K192541DigiX FDXAllengers Medical Systems Limited20195—
+4K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…Omega Medical Imaging, LLC20190—
+4K182415Alphenix, INFX-8000F/B, V8.0Canon Medical Systems Corporation201805
+4K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K162529DigiX FDXAllengers Medical Systems Limited20176—
+4K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+4K161019Uroview FDPausch Medical GmbH201621
+4K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+4K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+4K151850McKesson CardiologyMckesson Israel, Ltd.20152—
+4K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+4K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+4K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+4K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+4K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+4K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+4K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+4K123575MammoworkstationImage Diagnost International GmbH20132—
+4K122768GenesisDornier Medtech America, Inc.20134—
+4K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+4K121513Multix FusionSiemens Medical Solution2012324
+4K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+4K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+4K120073Infx-8000V withToshibamedical Systems Corporation2012203
+4K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+4K113052Infinix-CciToshiba America Medical Systems, In.C201171
+4K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+4K112054Infinix CF-I/SP and Infinix VF-I/SP Model Infx-8000VToshiba Medical Systems Corporation, Japan20110—
+4K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+4K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+4K101042BladeviewAccogent, LLC20100—
+4K102150Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc.201077
+4K082830Infx-8000H, Infinix-IToshiba America Medical Systems, In.C200812
+4K041949Allura Xper FD10Philips Medical Systems North America Co.20046448
+4K031836Philips Fresco Release 1Philips Medical Systems North America Co.200351—