510(k) Report

Devices descending from K022953

106 later devices reach Modification to Computed Oral Radiology System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093453Modification to Computed Oral Radiology SystemSchick Technologies, Inc.20090—
+1K072134Schick Computed Oral Radiology SystemSchick Technologies, Inc.200759—
+1K070664Progeny Imaging Software, Model# 500-405 (6,7,8).Progeny, Inc.20070—
+1K070505Krystal-X WifiOwandy200744—
+2K220277Digital Intraoral X-ray SensorShenzhen Xpectvision Technology Co., Ltd.20222—
+2K150823EDLENi Intra-Oral SensorEdlen Imaging, LLC201511—
+2K133206Z-Ray Intra-Oral Digital Radiography SystemZuma Dental, LLC20140—
+2K130088Port View, Digital X-Ray Sensor SystemGenoray Co., Ltd.20130—
+2K112380ClearvisionMidmark Corp.20110—
+2K103290Edlen Imaging - Gemini DusbEdlen Imaging, LLC201113—
+2K110768Computed Dental RadiographySchick Technologies, Inc.20110—
+2K090526Medical Image Processing Unit, Model EzsensorE-Woo Technology200918—
+2K092537Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540Toshiba America Electronic Components, Inc.20092—
+2K090458Dexis SensorDexis, LLC200918—
+2K081903Xios Plus Wall-ModuleSirona Dental Systems GmbH20080—
+2K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+3K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.20260—
+3K230916WeSensorPicopack, Inc.20230—
+3K223060DigiX FDXAllengers Medical Systems Limited20224—
+3K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+3K210312PlutoX Digital Intraoral X-Ray Imaging SystemIray Technology Taicang, Ltd.20215—
+3K202664Clio Prime and Clio PedoSota Precision Optics, Inc. Dba Sota Imaging20202—
+3K192541DigiX FDXAllengers Medical Systems Limited20195—
+3K172918DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)Kavo Dental Technologies, LLC201721
+3K163224JAZZ SOLO SensorJazz Imaging, LLC20171—
+3K162529DigiX FDXAllengers Medical Systems Limited20176—
+3K162619I View and Imagen SensorTrident S.R.L20161—
+3K151926QuickRay HD Intraoral SensorDenterprise International, Inc.201510—
+3K150797Digital Dental Intra Oral Sensor, EzSensor SmartRayence Co., Ltd.20153—
+3K143753Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor BioRayence Co., Ltd.20156—
+3K143000RIS500Ray Co., Ltd.20152—
+3K140056Digital Dental Intra Oral Sensor; Hdi 1000, Hdi 1000ARayence Co., Ltd.20140—
+3K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+3K121513Multix FusionSiemens Medical Solution2012324
+3K113360Medical Image Processing UnitHumanray Co,Ltd20125—
+3K102456Intraoral Belsensor GoldTakara Belmont USA, Inc.20111—
+3K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+3K110886Clio/CliosoftSota Precision Optics, Inc.20111—
+4K241495Jazz ClassicJazz Imaging20240—
+4K230985Planmeca VisoPlanmeca Oy20233—
+4K233053DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2…Dental Imaging Technologies Corporation20230—
+4K230998Digital Wireless Intraoral X-Ray SensorIray Imaging Technology (Haining) Limited20230—
+4K230811Digital Intraoral X-Ray SensorIray Imaging Technology (Haining) Limited20230—
+4K221955Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20Realcloud Imaging Inc. Dba Realcloud Imaging20221—
+4K220422Dental sensors NanoPix1, NanoPix2Iray Technology Taicang, Ltd.20221—
+4K213637JAZZ Solo sensorJazz Imaging, LLC Dba Jazz Imaging20210—
+4K212279Digital Intraoral X-ray Imaging SystemIray Technology Taicang, Ltd.20210—
+4K212103StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2Fona S.R.L20210—
+4K211688DC-Air and Athlos-1 and Athlos-AirAthlos OY20210—
+4K203116SensorXDurr Dental SE20210—
+4K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+4K201247Intraoral SensorDentium Co., Ltd (Ict Branch)20200—
+4K200284R-Sensor, R-SensorRemedi Co., Ltd.20200—
+4K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+4K181636AuroraSodium Systems, LLC20180—
+4K181358Televere Digital Dental Imaging SystemTelevere Systems, Inc.20180—
+4K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+4K163282Apex Dental SensorsMasterlink, LLC20172—
+4K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+4K153710Tuxedo Digital Dental SensorLed Dental, Inc.20160—
+4K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+4K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+4K153060Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-SRayence Co., Ltd.20152—
+4K151707EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio iRayence Co., Ltd.20155—
+4K150663Diagnostic X-ray SystemOsko, Inc.20150—
+4K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+4K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+4K123419Eva Select Digital Dental Imaging SystemAfp Imaging Corp.20120—
+4K121132Ezsensor P Digital Intraoral SensorHumanray Co,Ltd20124—
+5K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+5K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+5K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+5K241649DUO1 and DUO2Zinnovi, Inc.20240—
+5K232552TuxDeluxe (Size 1 6100B, Size 2 6101B)Tuxedo Imaging, LLC20230—
+5K232255EZSensor XHDQpix Solutions, Inc.20233—
+5K223550DMXDel Medical, Inc.20230—
+5K202369RXS 1000Rolence Enterprise, Inc.20210—
+5K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+5K200625I-View Gold and Imagen Gold Dental SensorsTrident S.R.L20200—
+5K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+5K190234ODI HD Dental SensorCnd Global Technologies, Inc.20190—
+5K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+5K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+5K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+5K173646FS ErgoPalodex Group OY20170—
+5K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+5K140060Digital Dental Intra Oral Sensor, Hdi 2000, Hdi 2000ARayence Co., Ltd.20140—
+6K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+6K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.20242—
+6K233543YSIO X.preeSiemens Medical Solutions20241—
+6K231995AcuityUDRRadmedix, LLC20230—
+6K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+6K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+6K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+7K261663EzSensor HDQpix Solutions, Inc.20260—
+7K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+7K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.20251—
+7K250738YSIO X.preeSiemens Medical Solutions20250—
+7K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+8K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—