510(k) Report

Devices descending from K060259

47 later devices reach Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+1K091658GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100…GE Healthcare2009111
+1K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C2008231
+1K061163Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Ge Medical Systems, LLC20062238
+2K112054Infinix CF-I/SP and Infinix VF-I/SP Model Infx-8000VToshiba Medical Systems Corporation, Japan20110—
+2K111209Integrated Innova - S5I System OptionGE Healthcare201182
+2K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+2K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+2K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+3K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+3K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+3K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+3K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+3K120073Infx-8000V withToshibamedical Systems Corporation2012203
+3K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+3K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+4K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+4K213479D²RS and D²RS 9090Stephanix20211—
+4K200887AS-10Canon, Inc.20200—
+4K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+4K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+4K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+4K133278Discovery Igs 740GE Medical Systems SCS201445
+4K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+5K252503Intelligent NRCanon, Inc.20260—
+5K2434463DXRGE Medical Systems SCS20250—
+5K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+5K221335D²RS and D²RS 9090Stephanix20220—
+5K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation201592
+5K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation20147—
+6K251199Allia MoveoGE Medical Systems SCS202501
+6K152696Infx-8000V, V6.20Toshibamedical Systems Corporation201681
+6K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+7K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+7K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+8K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+8K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+8K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+9K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation201841
+9K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+10K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation202032
+10K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+11K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+11K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+12K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation20251—
+12K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+13K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation20260—