510(k) Report

Devices descending from K031448

66 later devices reach RSV (Radiology System Visiodent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053172Universal-X (Usa) or /Krystal-X (Europe)Owandy Sas200658—
+1K061114WDS, Size 2 and Size 2Cefla S.C.R.L.20065—
+1K060640Digirex Digital Dental Radiography SystemDentamerica20060—
+2K100960WDS X-Pod and Zen-X Digital X-Ray SensorsCefla Dental Group20100—
+2K093105VisteoOwandy201012—
+2K080738Dentron SensorDentron Systems, LLC20083—
+2K070505Krystal-X WifiOwandy200744—
+3K133271Opteo, Videograph HDOwandy201411—
+3K092537Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540Toshiba America Electronic Components, Inc.20092—
+3K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+4K223060DigiX FDXAllengers Medical Systems Limited20224—
+4K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+4K192541DigiX FDXAllengers Medical Systems Limited20195—
+4K162529DigiX FDXAllengers Medical Systems Limited20176—
+4K151926QuickRay HD Intraoral SensorDenterprise International, Inc.201510—
+4K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+4K121513Multix FusionSiemens Medical Solution2012324
+4K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+4K110886Clio/CliosoftSota Precision Optics, Inc.20111—
+5K241495Jazz ClassicJazz Imaging20240—
+5K230985Planmeca VisoPlanmeca Oy20233—
+5K230916WeSensorPicopack, Inc.20230—
+5K212103StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2Fona S.R.L20210—
+5K211688DC-Air and Athlos-1 and Athlos-AirAthlos OY20210—
+5K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+5K200284R-Sensor, R-SensorRemedi Co., Ltd.20200—
+5K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+5K181636AuroraSodium Systems, LLC20180—
+5K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+5K163282Apex Dental SensorsMasterlink, LLC20172—
+5K162619I View and Imagen SensorTrident S.R.L20161—
+5K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+5K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+5K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+5K150663Diagnostic X-ray SystemOsko, Inc.20150—
+5K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+5K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+6K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+6K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+6K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+6K223550DMXDel Medical, Inc.20230—
+6K202369RXS 1000Rolence Enterprise, Inc.20210—
+6K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+6K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+6K190234ODI HD Dental SensorCnd Global Technologies, Inc.20190—
+6K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+6K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+6K181358Televere Digital Dental Imaging SystemTelevere Systems, Inc.20180—
+6K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+6K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+7K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+7K233543YSIO X.preeSiemens Medical Solutions20241—
+7K231995AcuityUDRRadmedix, LLC20230—
+7K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+7K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+7K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+8K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+8K250738YSIO X.preeSiemens Medical Solutions20250—
+8K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+9K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+9K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+10K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+10K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+11K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+11K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+11K233532MULTIX Impact ESiemens Medical Solutions20230—