510(k) Report

Devices descending from K003787

104 later devices reach Newtom QR-DVT 9000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061284I-Cat ScannerImaging Sciences Intl., Inc.2006312
+1K051980DVT ScannerImaging Sciences Intl., Inc.2005123
+1K041137Newtom 3G QR-DVT 9000Aperio Services, LLC20043—
+1K033248Hitachi CB Mercuray Dental Cone-Beam X-Ray SystemHitachi Medical Systems America, Inc.200318—
+1K032243Minicat DentocatXoran Technologies, Inc.200393
+1K0304503D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc.200388—
+2K133620Cone Beam 3D and 2D Panoramic Dental Imaging SystemImaging Sciences International20146—
+2K113421MinicatXoran Technologies, Inc.201211
+2K092171Volux, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd.20100—
+2K082410MASTER3DSE-Woo Technology20080—
+2K081847Picasso Master, Ect and Master 3DE-Woo Technology20080—
+2K073704I-DixelJ. Morita USA, Inc.20080—
+2K073350Scanora 3DSoredex Palodex Group OY200724—
+2K072357Newtom VG Computed Tomography X-Ray SystemAfp Imaging Corp.20072—
+2K063622Finecube Dental CTThe Yoshida Dental Mfg. Co., Ltd.200711—
+2K061834Xcat; Xcat for NeuroXoran Technologies, Inc.20066—
+2K060892GalileosSirona Dental Systems GmbH200617—
+2K0525873D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc.200566—
+3K210257Xoran Workstation, Model 10050Xoran Technologies, LLC20210—
+3K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International20162—
+3K161881PreXion3D ExcelsiorPrexion Corporation20162—
+3K143435Planmed VerityPlanmed OY20152—
+3K133797Qmaster-H/RevoTelesystems Co., Ltd.20140—
+3K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd.20136—
+3K123070Galileos FamilySirona Dental Systems GmbH201313—
+3K121418Planmed VerityPlanmed OY20132—
+3K120948Prexion 3DThe Yoshida Dental Mfg. Co., Ltd.20120—
+3K110839Scanora 3DSoredex Palodex Group OY20114—
+3K110260Newtom 5G / Newtom 5G Version FPQr S.R.L.20110—
+3K103711Orthophos XG 3D / CephSirona Dental Systems GmbH20117—
+3K093683Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY201021—
+3K0736953D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1F8/F17J. Morita USA, Inc.20085—
+3K073696VeraviewepocsJ. Morita USA, Inc.200822—
+3K072574Alphard Cone Beam CT, Model X178Takara Belmont Corp.20072—
+3K060328Planmeca Promax 3DPlanmeca Oy200661—
+4K243337Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.20251—
+4K180918Planmed VerityPlanmed OY20181—
+4K173878PreXion3D ExcelsiorPrexion Corporation20181—
+4K163423Orthopantomograph OP300Palodex Group OY201721
+4K160723OnSight 3D Extremity SystemCarestream Health, Inc.20161—
+4K151137X-View, ImagenEdlen Imaging, LLC20160—
+4K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp.20162—
+4K150217Orthophos SLSirona Dental Systems GmbH20155—
+4K130297Scanora 3DXPalodex Group OY20130—
+4K122806Image Works PanouraMic International20132—
+4K122018OP300Palodex Group OY20128—
+4K111152Rotograph Evo 3DVilla Sistemi Medicali S.P.A.2011271
+4K101181Bel-CatTakara Belmont Corp.20111—
+4K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd.201111—
+4K103689Planmeca Promax 3D MidPlanmeca Oy20110—
+4K093590Planmeca Promax 3D MaxPlanmeca Oy201015—
+5K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.20260—
+5K252249Extremity CT Imaging SystemMars Bioimaging, Ltd.20260—
+5K230505Orthopantomograph™ OP 3D LXPalodex Group OY20231—
+5K213278Planmed VerityPlanmed OY20220—
+5K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephFona S.R.L20220—
+5K211159eco-x Series (eco-x, eco-x-s)Hdx Will Corp.20210—
+5K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica20211—
+5K201140AxeosDentsply Sirona20201—
+5K191616Orthophos SDentsply Sirona20190—
+5K182198Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd.20191—
+5K181983PreXion 3D ExcelsiorPrexion Corporation20180—
+5K161131FONA Pan/CephFona S.R.L20160—
+5K160140DENTRIa seriesHdx Will Corp.20169—
+5K160506Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy20167—
+5K133544OP300Palodex Group OY20147—
+5K123332Naomi-CTLk Consulting Group20130—
+5K130443I-Max Touch 3DOwandy201321
+5K122981Rayscan a-Expert 3DRay Co., Ltd.201324—
+5K121800Point 500 HD POINT500C HDPointnix Co., Ltd.20130—
+6K253959Primevision 3DDentsply Sirona20260—
+6K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)Palodex Group OY20240—
+6K230985Planmeca VisoPlanmeca Oy20233—
+6K222666X-View 3D Pan/X-View 2D PanTrident S.R.L20230—
+6K223816Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica20230—
+6K212254DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Hdx Will Corp.20211—
+6K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp.20181—
+6K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark…Villa Sistemi Medicali S.P.A.20181—
+6K181576Planmeca VisoPlanmeca Oy20184—
+6K180947Orthopantomograph OP 3DPalodex Group OY201821
+6K181136CS 9600Trophy201811
+6K171012Veraview X800J. Morita USA, Inc.20171—
+6K170813Orthopantomograph OP 3DPalodex Group OY201701
+6K160525RCT700Ray Co., Ltd.201611—
+6K142247Rayscan a-Expert 3DRay Co., Ltd.201522—
+6K131695Rayscan a-Expert 3DRay Co., Ltd.201323—
+7K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+7K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.20260—
+7K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+7K2013783D Accuitomo 150NJ. Morita USA, Inc.20210—
+7K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L.20200—
+7K200183CS 9600Trophy202001
+7K182614RCT700Ray Co., Ltd.20186—
+7K181452RCT800Ray Co., Ltd.201810—
+8K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+8K213226RCT700Ray Co., Ltd.20215—
+8K182805RCT800Ray Co., Ltd.20188—
+9K251798RCT700Ray Co., Ltd.20250—
+9K243903RCT600Ray Co., Ltd.20250—
+9K242805Dental Cone-beam Computed Tomography (FinScan F350)Changzhou Finno Medical Technology Co., Ltd.20250—