510(k) Report

Devices descending from K010304

54 later devices reach MXR-2000 Mobile X-Ray Unit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012663Easy Moving Mobile X-Ray Unit (Model SM-HF)Sedecal USA, Inc.2001531
+2K090322Easy Moving Plus, SM-XXHF-YYSedecal., Sa.20095031
+2K043002Sedecal Mobile X-Ray Units with Digital DetectorSedecal., Sa.200452—
+3K142492GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd.2014251
+3K101517Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa.2011164
+3K111725Mobilediagnost WDRSedecal., Sa.201148
+3K103597DX-D 100Agfa Healthcare N.V.201116
+3K063262AMX4-50 and AMX4-31 Mobile Digital Diagnostic Radiographic SystemsVirtual Imaging20060—
+4K191884DR 100sAgfa N.V.20190—
+4K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa.20161413
+4K150097GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd.2015242
+4K141895Mobilediagnost WDRSedecal., Sa.201432
+4K131314Ddrcruze (Digital Mobile Diagnostic X-Ray System)Swissray Medical AG20130—
+5K201340Aquila 320 D / Aquila 320 SVmi Tecnologias Ltda20201—
+5K192011PhoeniXSedecal., Sa.20198—
+5K191813MobileDiagnost wDR 2.2Sedecal., Sa.201914
+5K181874MX40 Mobile Digital X-ray SystemHuestis Machine Corporation20181—
+5K173018MDR17 Mobile Direct Radiographic SystemDel Medical, Inc.20170—
+5K173187MobileDiagnost M50Philips India Limited20170—
+5K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+5K162687Paragon 2Meridian Medical Systems, LLC20160—
+6K240284Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex…Shenzhen Browiner Tech Co., Ltd.20240—
+6K233678Radiography 7000 MPhilips Medical Systems Dmc GmbH202401
+6K212515MOVIX DReamyStephanix20210—
+6K212291PhoenixSedecal., Sa.202141
+6K212134Diagnostic X-ray System/PLX5200ANanjing Perlove Medical Equipment Co., Ltd.20210—
+6K192936Soltus 500Sedecal., Sa.201901
+6K171119GM85Samsung Electronics Co., Ltd.2017221
+7K232185SM-IVSedecal., Sa.20230—
+7K222951SM-VSedecal., Sa.20221—
+7K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.Sedecal., Sa.202201
+7K181629GC85ASamsung Electronics Co., Ltd.20185—
+7K181631GR40CWSamsung Electronics Co., Ltd.20185—
+7K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+7K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+8K260481GC85ASamsung Electronics Co., Ltd.20260—
+8K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+8K231577MOBILETT ImpactSiemens Medical Solutions20230—
+8K203188ADDH&abyz Co., Ltd.20213—
+8K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+8K182647GC70Samsung Electronics Co., Ltd.20180—
+8K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—
+8K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+9K220175GM85Samsung Electronics Co., Ltd.20223—
+9K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+9K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+10K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+10K222353GM85Samsung Electronics Co., Ltd.202223
+10K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+11K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+11K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—
+11K242651GM85Samsung Electronics Co., Ltd.20240—
+12K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+12K251443PROMODRGEM Corporation20250—