510(k) Report

Devices descending from K982196

221 later devices reach Digital Radiographic Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102615Wireless DR Imaging Option-WDR1Ge Medical Systems, LLC201061
+1K041922GE Tethered Portable Digital Radiographic DetectorGeneral Electric Co.200420—
+1K992794Stingray DR, Model 1Infimed, Inc.1999103—
+1K992066Revolution TX/I Digital Radiographic Table SystemGE Medical Systems1999104—
+2K161459Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)Varian Medical Systems, X-Ray Products-Infimed20165—
+2K103448Brivo XR385Ge Medical Systems, LLC201141
+2K103476BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMXGe Medical Systems, LLC201158
+2K093066I5 Digital X-Ray Imaging System, Model I5Infimed, Inc.201022—
+2K063283Definium 5000 X-Ray SystemSedecal., Sa.2006143
+2K052661Quix Digital Radiographic UpgradeEdge Medical Devices, Ltd.20060—
+2K024147Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc.200378—
+2K012389Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc.20011034
+3K183212Nexus DR Digital X-ray Imaging System with stitchingVarex Imaging Corporation20182—
+3K171138Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation20174—
+3K162529DigiX FDXAllengers Medical Systems Limited20176—
+3K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd.20160—
+3K142383Optima XR200amx, Optima XR220amxGe Medical Systems, LLC201448
+3K141381DuradiagnostPhilips Healthcare (Suzhou) Co., Ltd.201437
+3K123105Xgeo GU60Samsung Electronics Co., Ltd.20130—
+3K122726Cpi Rad VisionCommunications & Power Industries Canada, Inc.20130—
+3K123098Xgeo GC80Samsung Electronics Co., Ltd.201348—
+3K122495Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorPerkinelmer, Inc.201213—
+3K121854System, X-Ray, StationaryBeijing Sinopharm Hundric Mediline Info. Tech. Co.20120—
+3K120020Vivix-SVieworks Co., Ltd.201230—
+3K112180I5 Digital X-Ray Imaging System (with SDX-4336CP)Infimed, Inc.20110—
+3K111312SanteviewSehyun Co., Ltd.20110—
+3K103416Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc.201117—
+3K101833Infistitch for I5 Digital X-Ray Imaging System, Model I5Infimed, Inc.20101—
+3K092669DX-D Imaging PackageAgfa Healthcare N.V.2009341
+3K083640Digital X-Ray Imaging System, Model: CXD-DR80DChoong Wae Medical Corp.20092—
+3K083645Radstar Family, Models: Radstar 4343 & Variations5 Star Medical, Inc.20096—
+3K080742Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH20085—
+3K072766Pvmed DDR 2520 Digital Imaging SystemPortavision Medical20070—
+3K051967Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare2005299
+3K050704Modification to: Revolution XR/D Digital Radiographic Imaging System with Image Pasting…General Electric Co.200572
+3K042602Revolution XR/D Digital Radiographic Imaging System with Manual Image PastingGe Medical Systems, LLC20058—
+3K013481Dual Energy and Tissue Equalization Software OptionGE Medical Systems200145—
+4K201640DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd.202002
+4K190330DRX-Evolution/Plus with Dual EnergyCarestream Health, Inc.20192—
+4K192541DigiX FDXAllengers Medical Systems Limited20195—
+4K190146Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation20191—
+4K172951Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)Varex Imaging Corporation20173—
+4K163410DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd.201714
+4K162990Optima XR240amxGe Medical Systems, LLC201632
+4K143270Optima XR646Ge Hualun Medical Systems Co., Ltd.20156—
+4K140551Perkinelmer, Xrpad 4336 Med Flat Panel DetectorPerkinelmer, Inc.201412—
+4K140326Xgeo GF50Samsung Electronics Co., Ltd.201420—
+4K140334Xgeo GC80Samsung Electronics Co., Ltd.201440—
+4K140235Xgeo GR40CWSamsung Electronics Co., Ltd.201423—
+4K132847I2CIon Beam Applications S.A.201303
+4K132261Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC2013211
+4K131211Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH20133—
+4K130318Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Varian Medical Systems, X-Ray Products-Infimed201315—
+4K122736DX-D Imaging PackageAgfa Healthcare N.V.201325—
+4K122865Vivix-S WirelessVieworks Co., Ltd.201328—
+4K122866Vivix-S with VxvueVieworks Co., Ltd.201311—
+4K122454Fujifilm Dual Energy Subtraction (Des) Software OptionFujifilm Medical System U.S.A., Inc.20126—
+4K121499Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray SystemFujifilm Medical System U.S.A., Inc.20126—
+4K121095DX-D Imaging PackageAgfa Healthcare N.V.20123—
+4K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+4K102327Clearvision DR 7000FJpi Healthcare Co, Ltd.20120—
+4K111344I5 Digital X-Ray Imaging System (with Flaatz 560)Infimed, Inc.20110—
+4K101779Clearvision DR 2000 Digital Radiography X-Ray SystemJpi Healthcare Co, Ltd.20110—
+4K103597DX-D 100Agfa Healthcare N.V.201116
+4K103050DX-D 300Agfa Healthcare N.V.20108—
+4K101435Imix Panorad and SomaradImix Adr Finland OY20101—
+4K092363Softview, Model 2.01Riverain Medical Group201034—
+4K092653Verisuite and Verisuite-Particle, Version 1.8Medcom GmbH20093—
+5K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging Corporation20260—
+5K233381DRX-Evolution Plus SystemCarestream Health, Inc.20241—
+5K223060DigiX FDXAllengers Medical Systems Limited20224—
+5K201725DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit.202003
+5K193238Nexus DR Digital X-Ray Imaging System (with vSharp)Varex Imaging Corporation20190—
+5K191504PowerDRRadiology Information Systems, Inc.20190—
+5K191884DR 100sAgfa N.V.20190—
+5K191699Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd.201913
+5K183275DR 800 with TomosynthesisAgfa N.V.201983
+5K181789VeriSuiteMedcom GmbH20180—
+5K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+5K173602Optima XR240amx, AutoGridGe Medical Systems, LLC201822
+5K172869Discovery XR656 HDGe Hualun Medical Systems Co., Ltd.201751
+5K162344Innolux RicInnolux Corporation20161—
+5K161201ClearRead CTRiverain Technologies, LLC20165—
+5K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorPerkinelmer, Inc.20161—
+5K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel DetectorPerkinelmer, Inc.20160—
+5K152294FDR Visionary SuiteShimadzu Corporation201615
+5K152244RADspeed ProShimadzu Corporation201632
+5K152894Vivix-S 1717NVieworks Co., Ltd.20169—
+5K152855Vivix-S 1012NVieworks Co., Ltd.20165—
+5K152094GR40CWSamsung Electronics Co., Ltd.201522—
+5K150929CareView 1500Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.201512—
+5K151419GF50ASamsung Electronics Co., Ltd.201519—
+5K151221Kubtec DIGIVIEW 395Kub Technologies, Inc.20150—
+5K150165GC85ASamsung Electronics Co., Ltd.201536—
+5K142341X-Ray TV System Sonialvision G4Shimadzu Corp.201552
+5K143029Digital Diagnostic X-ray System (GC80)Samsung Electronics Co., Ltd.201501
+5K142492GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd.2014251
+5K142698PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc.20147—
+5K142184DX-D Imaging PackageAgfa Healthcare N.V.20142—
+5K141602DX-D Imaging PackageAgfa Healthcare N.V.20140—