510(k) Report

Devices descending from K884930

293 later devices reach Compax Model 40, 400, 400T through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992066Revolution TX/I Digital Radiographic Table SystemGE Medical Systems1999104—
+1K971452Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc.19971978
+2K063421DX-SIAgfa Corp.20066—
+2K013218Fuji Speed Suite, Fuji Speed Sute Phase IIFujifilm Medical System U.S.A., Inc.200111
+2K012389Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc.20011034
+2K983732Thorax FD and Multix FDSiemens Medical Solutions USA, Inc.19991871
+3K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd.20160—
+3K123105Xgeo GU60Samsung Electronics Co., Ltd.20130—
+3K123098Xgeo GC80Samsung Electronics Co., Ltd.201348—
+3K121854System, X-Ray, StationaryBeijing Sinopharm Hundric Mediline Info. Tech. Co.20120—
+3K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc.20100—
+3K083640Digital X-Ray Imaging System, Model: CXD-DR80DChoong Wae Medical Corp.20092—
+3K071546EOSBiospace Med200771
+3K072010Quantum Direx SystemQuantum Medical Imaging, LLC20075—
+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
+3K033577Uniscan, Pulmoscan, Pulmoscan Radiographic SystemsMedlink Imaging20050—
+3K042602Revolution XR/D Digital Radiographic Imaging System with Manual Image PastingGe Medical Systems, LLC20058—
+3K013826Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc.2002818
+3K013481Dual Energy and Tissue Equalization Software OptionGE Medical Systems200145—
+3K992794Stingray DR, Model 1Infimed, Inc.1999103—
+4K190330DRX-Evolution/Plus with Dual EnergyCarestream Health, Inc.20192—
+4K161459Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)Varian Medical Systems, X-Ray Products-Infimed20165—
+4K143270Optima XR646Ge Hualun Medical Systems Co., Ltd.20156—
+4K140326Xgeo GF50Samsung Electronics Co., Ltd.201420—
+4K140334Xgeo GC80Samsung Electronics Co., Ltd.201440—
+4K140235Xgeo GR40CWSamsung Electronics Co., Ltd.201423—
+4K132261Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC2013211
+4K123740EOSEos Imaging201351
+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—
+4K102327Clearvision DR 7000FJpi Healthcare Co, Ltd.20120—
+4K120721EOSEos Imaging20126—
+4K101779Clearvision DR 2000 Digital Radiography X-Ray SystemJpi Healthcare Co, Ltd.20110—
+4K092363Softview, Model 2.01Riverain Medical Group201034—
+4K093066I5 Digital X-Ray Imaging System, Model I5Infimed, Inc.201022—
+4K080905Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC20084—
+4K052661Quix Digital Radiographic UpgradeEdge Medical Devices, Ltd.20060—
+4K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc.2006803
+4K024147Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc.200378—
+5K233381DRX-Evolution Plus SystemCarestream Health, Inc.20241—
+5K193574Q-Rad SystemCarestream Health, Inc.20203—
+5K191699Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd.201913
+5K183275DR 800 with TomosynthesisAgfa N.V.201983
+5K183212Nexus DR Digital X-ray Imaging System with stitchingVarex Imaging Corporation20182—
+5K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+5K172869Discovery XR656 HDGe Hualun Medical Systems Co., Ltd.201751
+5K171138Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation20174—
+5K162529DigiX FDXAllengers Medical Systems Limited20176—
+5K161201ClearRead CTRiverain Technologies, LLC20165—
+5K152294FDR Visionary SuiteShimadzu Corporation201615
+5K152244RADspeed ProShimadzu Corporation201632
+5K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+5K152094GR40CWSamsung Electronics Co., Ltd.201522—
+5K151419GF50ASamsung Electronics Co., Ltd.201519—
+5K150165GC85ASamsung Electronics Co., Ltd.201536—
+5K142341X-Ray TV System Sonialvision G4Shimadzu Corp.201552
+5K143029Digital Diagnostic X-ray System (GC80)Samsung Electronics Co., Ltd.201501
+5K142773EOS SystemEos Imaging20154—
+5K142492GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd.2014251
+5K133442Bone Suppression SoftwareCarestream Health, Inc.20140—
+5K122726Cpi Rad VisionCommunications & Power Industries Canada, Inc.20130—
+5K123526Clearread +ConfirmRiverain Technologies201225—
+5K120020Vivix-SVieworks Co., Ltd.201230—
+5K111776Deltaview Model 2.1Riverain Medical Group,Llc20110—
+5K112180I5 Digital X-Ray Imaging System (with SDX-4336CP)Infimed, Inc.20110—
+5K111312SanteviewSehyun Co., Ltd.20110—
+5K103416Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc.201117—
+5K101833Infistitch for I5 Digital X-Ray Imaging System, Model I5Infimed, Inc.20101—
+5K092669DX-D Imaging PackageAgfa Healthcare N.V.2009341
+5K083645Radstar Family, Models: Radstar 4343 & Variations5 Star Medical, Inc.20096—
+5K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+5K080614DR Vision Neo, DR Vision DouAlmana Medical Imaging20080—
+5K080742Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH20085—
+5K072766Pvmed DDR 2520 Digital Imaging SystemPortavision Medical20070—
+5K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+6K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+6K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+6K250788Definium Tempo SelectGe Hualun Medical Systems Co., Ltd.20250—
+6K242919V5med Lung AIV5med, Inc.20250—
+6K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+6K233719FDR Visionary SuiteShimadzu Corporation20240—
+6K233722RADspeed ProShimadzu Corporation202401
+6K231892Definium Pace SelectGe Hualun Medical Systems Co., Ltd.202311
+6K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH20231—
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K223060DigiX FDXAllengers Medical Systems Limited20224—
+6K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+6K212690qXR-BTQure.Ai Technologies20210—
+6K212145DR 800 with DSA, DR 800Agfa N.V.20210—
+6K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+6K201373DRX-CompassCarestream Health, Inc.202021
+6K193262DR 600 with TomosynthesisAgfa N.V.20204—
+6K200018HAD1717MCH&Abyz20200—
+6K192541DigiX FDXAllengers Medical Systems Limited20195—
+6K190373SonialVision G4Shimadzu Corporation201942
+6K190146Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation20191—
+6K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+6K182647GC70Samsung Electronics Co., Ltd.20180—
+6K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—