510(k) Report

Devices descending from K926258

382 later devices reach DLX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993037LCV+ Version 2Ge Medical Systems, Inc.20003306
+1K993792Smart Vessel Analysis (Smart VA) OptionGe Medical Systems, Inc.199960—
+1K992666Video Plus System, Series 95000Camtronics, Ltd.19991—
+2K100102CS-Series-FPOmega Medical Imaging, Inc.20108—
+2K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+2K060779Advance Vessel Analysis IIGE Healthcare200655—
+2K050489Innova 2100Ge Medical Systems, LLC20057527
+2K033361Viatronix V3D Vascular, Revision 1.0Viatronix, Inc.200322—
+2K031638Cardio Vascular Information Enhanced WorkstationElectromed Imaging, Inc.20030—
+2K023178Innova 4100Ge Medical Systems, Inc.20029725
+2K022322Innova and Innova 2000 SGe Medical Systems, Inc.2002787
+2K021021Modular Angiography System Axiom ArtisSiemens Medical Solutions USA, Inc.200221821
+2K020055Philips Integris Allura 9 with FD OptionPhilips Medical Systems20021242
+3K200626VesselIQ XpressGE Medical Systems SCS20210—
+3K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+3K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC20127—
+3K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+3K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+3K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+3K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+3K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+3K091658GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100…GE Healthcare2009111
+3K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+3K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+3K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc.20087239
+3K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+3K063628Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions2006183
+3K061163Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Ge Medical Systems, LLC20062238
+3K061370Cardiq FusionGE Healthcare200651—
+3K060259Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC2006474
+3K052412Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQGE Healthcare20057450
+3K041780New BridMedical Imaging Solutions, Inc.20040—
+3K033244Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table OptionGe Medical Systems, Inc.2003758
+3K031637Innova 3100GE Medical Systems20037625
+3K024200Innova 2000 and Innova 2000S (Mobile Version)Ge Medical Systems, Inc.200307
+3K022899Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co.20021148
+4K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+4K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+4K240786AutoChamberHeartLung Corporation20241—
+4K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+4K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+4K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+4K190868Cleerly LabsCleerly, Inc.20197—
+4K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC20194—
+4K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+4K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC20181—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+4K152352Stereo 3D option for Vision ApplicationsGE Medical Systems SCS20161—
+4K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+4K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+4K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+4K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+4K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+4K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+4K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+4K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+4K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+4K112720Mckesson Horizon CardiologyMckesson Israel, Ltd.20123—
+4K113543ONDEMAND3DCybermed, Inc.20119—
+4K111209Integrated Innova - S5I System OptionGE Healthcare201182
+4K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+4K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc.201120—
+4K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+4K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+4K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+4K091166IMRXImris, Inc.20091—
+4K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+4K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+4K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+4K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+4K081630Mammo WorkstationImage Diagnost International GmbH20084—
+4K081624Infx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C2008138
+4K081621Infx-8000C (Infinix CC-I and VC-I)Toshiba America Medical Systems, In.C2008101
+4K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C2008231
+4K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+4K081018Syngo Dynamics Version 7.0Siemens Medical Solutions20088—
+4K031333Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc.200311325
+5K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+5K252029AI-CVDHeartLung Corporation20250—
+5K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+5K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+5K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+5K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+5K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+5K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS20220—
+5K223060DigiX FDXAllengers Medical Systems Limited20224—
+5K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+5K213479D²RS and D²RS 9090Stephanix20211—
+5K212890Nyquist.IQOmega Medical Imaging, LLC20210—
+5K212336Soteria.AIOmega Medical Imaging, LLC20211—
+5K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+5K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+5K201172CFP-3131, CFP-2222Mx Imaging, Inc.20200—
+5K200887AS-10Canon, Inc.20200—
+5K192541DigiX FDXAllengers Medical Systems Limited20195—
+5K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…Omega Medical Imaging, LLC20190—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K182415Alphenix, INFX-8000F/B, V8.0Canon Medical Systems Corporation201805