510(k) Report

Devices descending from K945375

102 later devices reach Advantx Lca through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051980DVT ScannerImaging Sciences Intl., Inc.2005123
+1K032243Minicat DentocatXoran Technologies, Inc.200393
+1K022322Innova and Innova 2000 SGe Medical Systems, Inc.2002787
+2K113421MinicatXoran Technologies, Inc.201211
+2K063622Finecube Dental CTThe Yoshida Dental Mfg. Co., Ltd.200711—
+2K061834Xcat; Xcat for NeuroXoran Technologies, Inc.20066—
+2K050489Innova 2100Ge Medical Systems, LLC20057527
+2K031637Innova 3100GE Medical Systems20037625
+2K024200Innova 2000 and Innova 2000S (Mobile Version)Ge Medical Systems, Inc.200307
+3K210257Xoran Workstation, Model 10050Xoran Technologies, LLC20210—
+3K143435Planmed VerityPlanmed OY20152—
+3K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd.20136—
+3K121418Planmed VerityPlanmed OY20132—
+3K120948Prexion 3DThe Yoshida Dental Mfg. Co., Ltd.20120—
+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
+3K072574Alphard Cone Beam CT, Model X178Takara Belmont Corp.20072—
+3K061163Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Ge Medical Systems, LLC20062238
+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
+4K180918Planmed VerityPlanmed OY20181—
+4K161881PreXion3D ExcelsiorPrexion Corporation20162—
+4K160723OnSight 3D Extremity SystemCarestream Health, Inc.20161—
+4K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp.20162—
+4K152352Stereo 3D option for Vision ApplicationsGE Medical Systems SCS20161—
+4K111209Integrated Innova - S5I System OptionGE Healthcare201182
+4K101181Bel-CatTakara Belmont Corp.20111—
+4K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+4K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+4K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+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
+5K252249Extremity CT Imaging SystemMars Bioimaging, Ltd.20260—
+5K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS20220—
+5K213278Planmed VerityPlanmed OY20220—
+5K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica20211—
+5K182415Alphenix, INFX-8000F/B, V8.0Canon Medical Systems Corporation201805
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+5K173878PreXion3D ExcelsiorPrexion Corporation20181—
+5K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+5K123332Naomi-CTLk Consulting Group20130—
+5K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+5K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+5K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+5K120073Infx-8000V withToshibamedical Systems Corporation2012203
+5K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+5K113052Infinix-CciToshiba America Medical Systems, In.C201171
+5K112054Infinix CF-I/SP and Infinix VF-I/SP Model Infx-8000VToshiba Medical Systems Corporation, Japan20110—
+5K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+5K082830Infx-8000H, Infinix-IToshiba America Medical Systems, In.C200812
+6K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+6K223816Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica20230—
+6K213479D²RS and D²RS 9090Stephanix20211—
+6K200887AS-10Canon, Inc.20200—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+6K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+6K182546Alphenix, INFX-8000H/B, V8.0Canon Medical Systems Corporation201802
+6K181983PreXion 3D ExcelsiorPrexion Corporation20180—
+6K152697Infx-8000C, V6.20Toshibamedical Systems Corporation201635
+6K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+6K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation20152—
+6K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation20143—
+6K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+6K133278Discovery Igs 740GE Medical Systems SCS201445
+6K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+7K252503Intelligent NRCanon, Inc.20260—
+7K2434463DXRGE Medical Systems SCS20250—
+7K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+7K221335D²RS and D²RS 9090Stephanix20220—
+7K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+7K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA20181—
+7K181804Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation201823
+7K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation201592
+7K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation20147—
+8K251199Allia MoveoGE Medical Systems SCS202501
+8K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+8K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation202117
+8K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+8K152696Infx-8000V, V6.20Toshibamedical Systems Corporation201681
+8K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+9K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+9K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+9K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+10K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+10K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+10K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+10K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+10K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+11K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+11K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+11K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation201841
+11K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+12K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+12K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation202032
+12K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+13K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+13K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+14K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation20251—