510(k) Report

Devices descending from K023178

97 later devices reach Innova 4100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+1K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+1K063628Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions2006183
+1K041780New BridMedical Imaging Solutions, Inc.20040—
+1K031637Innova 3100GE Medical Systems20037625
+2K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+2K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+2K112720Mckesson Horizon CardiologyMckesson Israel, Ltd.20123—
+2K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+2K081630Mammo WorkstationImage Diagnost International GmbH20084—
+2K081018Syngo Dynamics Version 7.0Siemens Medical Solutions20088—
+2K061163Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Ge Medical Systems, LLC20062238
+2K052412Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQGE Healthcare20057450
+2K050489Innova 2100Ge Medical Systems, LLC20057527
+3K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+3K213479D²RS and D²RS 9090Stephanix20211—
+3K200887AS-10Canon, Inc.20200—
+3K152352Stereo 3D option for Vision ApplicationsGE Medical Systems SCS20161—
+3K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+3K151850McKesson CardiologyMckesson Israel, Ltd.20152—
+3K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+3K123575MammoworkstationImage Diagnost International GmbH20132—
+3K111209Integrated Innova - S5I System OptionGE Healthcare201182
+3K102150Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc.201077
+3K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+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
+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
+3K060259Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC2006474
+4K252503Intelligent NRCanon, Inc.20260—
+4K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS20220—
+4K221335D²RS and D²RS 9090Stephanix20220—
+4K182415Alphenix, INFX-8000F/B, V8.0Canon Medical Systems Corporation201805
+4K181080McKesson CardiologyChange Healthcare Israel, Ltd.20181—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K143361Mammo WorkstationGE Healthcare20151—
+4K123922Syngo DynamicsSiemens Medical Solutions USA, Inc.20135—
+4K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+4K120514CardiopacsLumedx20120—
+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
+4K082830Infx-8000H, Infinix-IToshiba America Medical Systems, In.C200812
+4K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C2008231
+5K212528Change Healthcare CardiologyChange Healthcare Israel, Ltd.20210—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+5K182546Alphenix, INFX-8000H/B, V8.0Canon Medical Systems Corporation201802
+5K171053syngo Dynamics Version VA30Siemens Healthcare GmbH20174—
+5K160937SenolrisGE Healthcare20160—
+5K152697Infx-8000C, V6.20Toshibamedical Systems Corporation201635
+5K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation20152—
+5K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation20143—
+5K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+5K133278Discovery Igs 740GE Medical Systems SCS201445
+5K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+5K112054Infinix CF-I/SP and Infinix VF-I/SP Model Infx-8000VToshiba Medical Systems Corporation, Japan20110—
+6K2434463DXRGE Medical Systems SCS20250—
+6K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+6K220832syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc.20223—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA20181—
+6K181804Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation201823
+6K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation201592
+6K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation20147—
+7K251199Allia MoveoGE Medical Systems SCS202501
+7K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+7K222428Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc.20222—
+7K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation202117
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K152696Infx-8000V, V6.20Toshibamedical Systems Corporation201681
+7K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+8K242551syngo Dynamics (Version VA41D)Siemens Healthcare GmbH20251—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+8K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+9K253689syngo Dynamics (VA41F)Siemens Healthcare GmbH20260—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+9K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+9K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation201841
+10K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation202032
+11K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+12K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+12K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+13K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation20251—
+13K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+14K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation20260—