510(k) Report

Devices descending from K052884

57 later devices reach Model DFP-8000D/FPD Digital Radiography System with Flat Panel Detector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100102CS-Series-FPOmega Medical Imaging, Inc.20108—
+1K081624Infx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C2008138
+1K081621Infx-8000C (Infinix CC-I and VC-I)Toshiba America Medical Systems, In.C2008101
+1K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C2008231
+2K182415Alphenix, INFX-8000F/B, V8.0Canon Medical Systems Corporation201805
+2K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+2K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC20127—
+2K113052Infinix-CciToshiba America Medical Systems, In.C201171
+2K112054Infinix CF-I/SP and Infinix VF-I/SP Model Infx-8000VToshiba Medical Systems Corporation, Japan20110—
+2K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+2K082830Infx-8000H, Infinix-IToshiba America Medical Systems, In.C200812
+3K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC20194—
+3K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+3K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+3K182546Alphenix, INFX-8000H/B, V8.0Canon Medical Systems Corporation201802
+3K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC20181—
+3K152697Infx-8000C, V6.20Toshibamedical Systems Corporation201635
+3K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation20152—
+3K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation20143—
+3K120073Infx-8000V withToshibamedical Systems Corporation2012203
+4K212890Nyquist.IQOmega Medical Imaging, LLC20210—
+4K212336Soteria.AIOmega Medical Imaging, LLC20211—
+4K201172CFP-3131, CFP-2222Mx Imaging, Inc.20200—
+4K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+4K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…Omega Medical Imaging, LLC20190—
+4K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA20181—
+4K181804Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation201823
+4K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+4K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+5K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+5K242488Soteria E-ViewOmega Medical Imaging, LLC20250—
+5K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation202117
+5K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+5K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation201592
+5K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation20147—
+6K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+6K152696Infx-8000V, V6.20Toshibamedical Systems Corporation201681
+6K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+7K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+7K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+7K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+7K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+8K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+8K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+8K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+8K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+8K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+9K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+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—