510(k) Report

Devices descending from K161345

14 later devices reach RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201340Aquila 320 D / Aquila 320 SVmi Tecnologias Ltda20201—
+1K192011PhoeniXSedecal., Sa.20198—
+1K181874MX40 Mobile Digital X-ray SystemHuestis Machine Corporation20181—
+1K173018MDR17 Mobile Direct Radiographic SystemDel Medical, Inc.20170—
+1K162687Paragon 2Meridian Medical Systems, LLC20160—
+2K240284Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex…Shenzhen Browiner Tech Co., Ltd.20240—
+2K212515MOVIX DReamyStephanix20210—
+2K212291PhoenixSedecal., Sa.202141
+2K212134Diagnostic X-ray System/PLX5200ANanjing Perlove Medical Equipment Co., Ltd.20210—
+2K192936Soltus 500Sedecal., Sa.201901
+3K232185SM-IVSedecal., Sa.20230—
+3K222951SM-VSedecal., Sa.20221—
+3K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.Sedecal., Sa.202201
+4K231577MOBILETT ImpactSiemens Medical Solutions20230—