510(k) Report

Devices descending from K012389

103 later devices reach Revolution XR/D Digital Radiographic Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd.20160—
+1K123105Xgeo GU60Samsung Electronics Co., Ltd.20130—
+1K123098Xgeo GC80Samsung Electronics Co., Ltd.201348—
+1K121854System, X-Ray, StationaryBeijing Sinopharm Hundric Mediline Info. Tech. Co.20120—
+1K083640Digital X-Ray Imaging System, Model: CXD-DR80DChoong Wae Medical Corp.20092—
+1K051967Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare2005299
+1K050704Modification to: Revolution XR/D Digital Radiographic Imaging System with Image Pasting…General Electric Co.200572
+1K042602Revolution XR/D Digital Radiographic Imaging System with Manual Image PastingGe Medical Systems, LLC20058—
+1K013481Dual Energy and Tissue Equalization Software OptionGE Medical Systems200145—
+2K190330DRX-Evolution/Plus with Dual EnergyCarestream Health, Inc.20192—
+2K143270Optima XR646Ge Hualun Medical Systems Co., Ltd.20156—
+2K140326Xgeo GF50Samsung Electronics Co., Ltd.201420—
+2K140334Xgeo GC80Samsung Electronics Co., Ltd.201440—
+2K140235Xgeo GR40CWSamsung Electronics Co., Ltd.201423—
+2K132261Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC2013211
+2K122454Fujifilm Dual Energy Subtraction (Des) Software OptionFujifilm Medical System U.S.A., Inc.20126—
+2K121499Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray SystemFujifilm Medical System U.S.A., Inc.20126—
+2K102327Clearvision DR 7000FJpi Healthcare Co, Ltd.20120—
+2K101779Clearvision DR 2000 Digital Radiography X-Ray SystemJpi Healthcare Co, Ltd.20110—
+2K092363Softview, Model 2.01Riverain Medical Group201034—
+3K233381DRX-Evolution Plus SystemCarestream Health, Inc.20241—
+3K191699Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd.201913
+3K183275DR 800 with TomosynthesisAgfa N.V.201983
+3K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+3K172869Discovery XR656 HDGe Hualun Medical Systems Co., Ltd.201751
+3K161201ClearRead CTRiverain Technologies, LLC20165—
+3K152294FDR Visionary SuiteShimadzu Corporation201615
+3K152244RADspeed ProShimadzu Corporation201632
+3K152094GR40CWSamsung Electronics Co., Ltd.201522—
+3K151419GF50ASamsung Electronics Co., Ltd.201519—
+3K150165GC85ASamsung Electronics Co., Ltd.201536—
+3K142341X-Ray TV System Sonialvision G4Shimadzu Corp.201552
+3K143029Digital Diagnostic X-ray System (GC80)Samsung Electronics Co., Ltd.201501
+3K142492GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd.2014251
+3K133442Bone Suppression SoftwareCarestream Health, Inc.20140—
+3K123526Clearread +ConfirmRiverain Technologies201225—
+3K111776Deltaview Model 2.1Riverain Medical Group,Llc20110—
+4K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+4K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+4K250788Definium Tempo SelectGe Hualun Medical Systems Co., Ltd.20250—
+4K242919V5med Lung AIV5med, Inc.20250—
+4K233719FDR Visionary SuiteShimadzu Corporation20240—
+4K233722RADspeed ProShimadzu Corporation202401
+4K231892Definium Pace SelectGe Hualun Medical Systems Co., Ltd.202311
+4K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH20231—
+4K221612ClearRead CTRiverain Technologies, Inc.20220—
+4K212690qXR-BTQure.Ai Technologies20210—
+4K212145DR 800 with DSA, DR 800Agfa N.V.20210—
+4K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+4K193262DR 600 with TomosynthesisAgfa N.V.20204—
+4K200018HAD1717MCH&Abyz20200—
+4K190373SonialVision G4Shimadzu Corporation201942
+4K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+4K182647GC70Samsung Electronics Co., Ltd.20180—
+4K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—
+4K18234814HK701G-WLg Electronics.Inc20187—
+4K181631GR40CWSamsung Electronics Co., Ltd.20185—
+4K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+4K18033217HK700G-WLg Electronics20188—
+4K173517RADspeed fitShimadzu Corporation20181—
+4K173612Optima XR646 HDGe Hualun Medical Systems Co., Ltd.201701
+4K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+4K160997GC85ASamsung Electronics Co., Ltd.201626—
+4K153401GR40CWSamsung Electronics Co., Ltd.201520—
+4K150097GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd.2015242
+5K252133Adaptix Ortho350Adaptix Limited20250—
+5K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+5K242678Definium Pace Select ETGe Hualun Medical Systems Co., Ltd.20240—
+5K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+5K22146110HQ701G-BLg Electronics.Inc20220—
+5K22139414HQ701G-BLg Electronics.Inc20221—
+5K22143417HQ701G-BLg Electronics.Inc20220—
+5K220175GM85Samsung Electronics Co., Ltd.20223—
+5K220518Skanrad 400Skanray Technologies Limited20220—
+5K212212Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions20221—
+5K203188ADDH&abyz Co., Ltd.20213—
+5K191877FLUOROspeedShimadzu Corporation201902
+5K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+5K18328617HK701G-WLg Electronics.Inc20182—
+5K172229GC85ASamsung Electronics Co., Ltd.201721—
+5K171119GM85Samsung Electronics Co., Ltd.2017221
+5K171085GMR40Neurologica Corporation, A Subsidiary OF201701
+5K163115GC70Samsung Electronics Co., Ltd.201623—
+6K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+6K22354614HQ721G-BLg Electronics.Inc20230—
+6K221281Multitom RaxSiemens Medical Solutions202201
+6K222353GM85Samsung Electronics Co., Ltd.202223
+6K21404414HQ901G-BLg Electronics.Inc20221—
+6K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+6K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+6K181629GC85ASamsung Electronics Co., Ltd.20185—
+6K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+7K260481GC85ASamsung Electronics Co., Ltd.20260—
+7K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+7K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+7K242651GM85Samsung Electronics Co., Ltd.20240—
+7K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+7K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+7K22055917HQ901G-BLg Electronics.Inc20220—
+8K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—