510(k) Report

Devices descending from K992066

104 later devices reach Revolution TX/I Digital Radiographic Table System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012389Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc.20011034
+2K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd.20160—
+2K123105Xgeo GU60Samsung Electronics Co., Ltd.20130—
+2K123098Xgeo GC80Samsung Electronics Co., Ltd.201348—
+2K121854System, X-Ray, StationaryBeijing Sinopharm Hundric Mediline Info. Tech. Co.20120—
+2K083640Digital X-Ray Imaging System, Model: CXD-DR80DChoong Wae Medical Corp.20092—
+2K051967Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare2005299
+2K050704Modification to: Revolution XR/D Digital Radiographic Imaging System with Image Pasting…General Electric Co.200572
+2K042602Revolution XR/D Digital Radiographic Imaging System with Manual Image PastingGe Medical Systems, LLC20058—
+2K013481Dual Energy and Tissue Equalization Software OptionGE Medical Systems200145—
+3K190330DRX-Evolution/Plus with Dual EnergyCarestream Health, Inc.20192—
+3K143270Optima XR646Ge Hualun Medical Systems Co., Ltd.20156—
+3K140326Xgeo GF50Samsung Electronics Co., Ltd.201420—
+3K140334Xgeo GC80Samsung Electronics Co., Ltd.201440—
+3K140235Xgeo GR40CWSamsung Electronics Co., Ltd.201423—
+3K132261Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC2013211
+3K122454Fujifilm Dual Energy Subtraction (Des) Software OptionFujifilm Medical System U.S.A., Inc.20126—
+3K121499Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray SystemFujifilm Medical System U.S.A., Inc.20126—
+3K102327Clearvision DR 7000FJpi Healthcare Co, Ltd.20120—
+3K101779Clearvision DR 2000 Digital Radiography X-Ray SystemJpi Healthcare Co, Ltd.20110—
+3K092363Softview, Model 2.01Riverain Medical Group201034—
+4K233381DRX-Evolution Plus SystemCarestream Health, Inc.20241—
+4K191699Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd.201913
+4K183275DR 800 with TomosynthesisAgfa N.V.201983
+4K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+4K172869Discovery XR656 HDGe Hualun Medical Systems Co., Ltd.201751
+4K161201ClearRead CTRiverain Technologies, LLC20165—
+4K152294FDR Visionary SuiteShimadzu Corporation201615
+4K152244RADspeed ProShimadzu Corporation201632
+4K152094GR40CWSamsung Electronics Co., Ltd.201522—
+4K151419GF50ASamsung Electronics Co., Ltd.201519—
+4K150165GC85ASamsung Electronics Co., Ltd.201536—
+4K142341X-Ray TV System Sonialvision G4Shimadzu Corp.201552
+4K143029Digital Diagnostic X-ray System (GC80)Samsung Electronics Co., Ltd.201501
+4K142492GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd.2014251
+4K133442Bone Suppression SoftwareCarestream Health, Inc.20140—
+4K123526Clearread +ConfirmRiverain Technologies201225—
+4K111776Deltaview Model 2.1Riverain Medical Group,Llc20110—
+5K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+5K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+5K250788Definium Tempo SelectGe Hualun Medical Systems Co., Ltd.20250—
+5K242919V5med Lung AIV5med, Inc.20250—
+5K233719FDR Visionary SuiteShimadzu Corporation20240—
+5K233722RADspeed ProShimadzu Corporation202401
+5K231892Definium Pace SelectGe Hualun Medical Systems Co., Ltd.202311
+5K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH20231—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K212690qXR-BTQure.Ai Technologies20210—
+5K212145DR 800 with DSA, DR 800Agfa N.V.20210—
+5K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+5K193262DR 600 with TomosynthesisAgfa N.V.20204—
+5K200018HAD1717MCH&Abyz20200—
+5K190373SonialVision G4Shimadzu Corporation201942
+5K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+5K182647GC70Samsung Electronics Co., Ltd.20180—
+5K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—
+5K18234814HK701G-WLg Electronics.Inc20187—
+5K181631GR40CWSamsung Electronics Co., Ltd.20185—
+5K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+5K18033217HK700G-WLg Electronics20188—
+5K173517RADspeed fitShimadzu Corporation20181—
+5K173612Optima XR646 HDGe Hualun Medical Systems Co., Ltd.201701
+5K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+5K160997GC85ASamsung Electronics Co., Ltd.201626—
+5K153401GR40CWSamsung Electronics Co., Ltd.201520—
+5K150097GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd.2015242
+6K252133Adaptix Ortho350Adaptix Limited20250—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K242678Definium Pace Select ETGe Hualun Medical Systems Co., Ltd.20240—
+6K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+6K22146110HQ701G-BLg Electronics.Inc20220—
+6K22139414HQ701G-BLg Electronics.Inc20221—
+6K22143417HQ701G-BLg Electronics.Inc20220—
+6K220175GM85Samsung Electronics Co., Ltd.20223—
+6K220518Skanrad 400Skanray Technologies Limited20220—
+6K212212Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions20221—
+6K203188ADDH&abyz Co., Ltd.20213—
+6K191877FLUOROspeedShimadzu Corporation201902
+6K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+6K18328617HK701G-WLg Electronics.Inc20182—
+6K172229GC85ASamsung Electronics Co., Ltd.201721—
+6K171119GM85Samsung Electronics Co., Ltd.2017221
+6K171085GMR40Neurologica Corporation, A Subsidiary OF201701
+6K163115GC70Samsung Electronics Co., Ltd.201623—
+7K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+7K22354614HQ721G-BLg Electronics.Inc20230—
+7K221281Multitom RaxSiemens Medical Solutions202201
+7K222353GM85Samsung Electronics Co., Ltd.202223
+7K21404414HQ901G-BLg Electronics.Inc20221—
+7K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+7K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+7K181629GC85ASamsung Electronics Co., Ltd.20185—
+7K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+8K260481GC85ASamsung Electronics Co., Ltd.20260—
+8K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+8K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+8K242651GM85Samsung Electronics Co., Ltd.20240—
+8K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+8K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+8K22055917HQ901G-BLg Electronics.Inc20220—