510(k) Report

Devices descending from K973642

96 later devices reach Orthopantomograph OP100 and Orthoceph OC100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063773Volumetric TomographyInstrumentarium Dental, Inc.200768—
+1K043612Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DInstrumentarium Corp. Imaging Division200510—
+1K030699Veraviewepocs Panoramic/Cephalometric X-Ray Unit with CephalometricJ. Morita Mfg. Corp.200324—
+1K021372Veraviewepocs Panoramic X-Ray Unit with Cephalometric CapabilityJ. Morita USA, Inc.20020—
+2K141700Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd.20146—
+2K122643Vantage Model V5000, V5100, V5000C, V5100CMidmark Corp.201312
+2K101661Myray HyperionCefla Dental Group20100—
+2K082350PAX-500VATECH Co., Ltd.200867—
+2K073696VeraviewepocsJ. Morita USA, Inc.200822—
+2K053220Veraview IC 5, Model XDP1J. Morita USA, Inc.20060—
+3K220423PAPAYA & PAPAYA PlusGenoray Co., Ltd.20220—
+3K201667Midmark Extraoral Imaging System (EOIS)Midmark Corporation20200—
+3K150354PAPAYA 3D PlusGenoray Co., Ltd.20154—
+3K093683Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY201021—
+3K090467Digital X-Ray Imaging System, Model Pax-UNI3DVATECH Co., Ltd.20101—
+3K090991Computed Tomography X-Ray System, Model Picasso-DuoE-Woo Technology20093—
+3K083917X-Ray, Tomography, Computed, DentalSuni Medical Imaging, Inc.20090—
+3K090171Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology200959—
+4K220392PAPAYA 3D & PAPAYA 3D PlusGenoray Co., Ltd.20220—
+4K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd.20201—
+4K151137X-View, ImagenEdlen Imaging, LLC20160—
+4K122806Image Works PanouraMic International20132—
+4K122018OP300Palodex Group OY20128—
+4K121400Pax-UNI3D, PHT-7500VATECH Co., Ltd.20120—
+4K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd.201111—
+4K102196Computed Tomography X-Ray SystemVATECH Co., Ltd.20112—
+4K102259Dental Computed Tomography X-Ray SystemVATECH Co., Ltd.201142—
+4K102124Dental Computed Tomography X-Ray SystemVATECH Co., Ltd.201015—
+5K250060GT300; GT300-CGenoray Co., Ltd.20250—
+5K182198Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd.20191—
+5K132983Ton-95LH, Pax-I3D OrthoVATECH Co., Ltd.20141—
+5K133544OP300Palodex Group OY20147—
+5K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd.20136—
+5K121800Point 500 HD POINT500C HDPointnix Co., Ltd.20130—
+5K120263Volux 21C, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd.201214—
+5K121412Pax-FLEX3D, PHT-7000VATECH Co., Ltd.201228—
+5K113672PCH-2500 Digital Extraoral Source X-Ray SystemVATECH Co., Ltd.201212—
+6K222666X-View 3D Pan/X-View 2D PanTrident S.R.L20230—
+6K180947Orthopantomograph OP 3DPalodex Group OY201821
+6K171012Veraview X800J. Morita USA, Inc.20171—
+6K163423Orthopantomograph OP300Palodex Group OY201721
+6K170813Orthopantomograph OP 3DPalodex Group OY201701
+6K160882PaX-i3D Green Premium (Model: PCT-90LH)VATECH Co., Ltd.20160—
+6K161881PreXion3D ExcelsiorPrexion Corporation20162—
+6K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp.20162—
+6K123070Galileos FamilySirona Dental Systems GmbH201313—
+6K122606PHT-6500; PHT-60CFO; Pax-I3DMtechgroup201227—
+6K122155PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source X-Ray SystemVATECH Co., Ltd.201211—
+7K230505Orthopantomograph™ OP 3D LXPalodex Group OY20231—
+7K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica20211—
+7K2013783D Accuitomo 150NJ. Morita USA, Inc.20210—
+7K173878PreXion3D ExcelsiorPrexion Corporation20181—
+7K170731System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i InsightVATECH Co., Ltd.20171—
+7K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International20162—
+7K152106Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd.201525—
+7K150217Orthophos SLSirona Dental Systems GmbH20155—
+7K133620Cone Beam 3D and 2D Panoramic Dental Imaging SystemImaging Sciences International20146—
+7K130419Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd.20137—
+7K130585PCH-2500 Digital Extraoral Source X-Ray System, Pax-I Digital Extraoral Source X-Ray…VATECH Co., Ltd.20130—
+7K130432PHT-6500, PHT-60CFOVATECH Co., Ltd.20130—
+8K243337Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.20251—
+8K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan…VATECH Co., Ltd.20240—
+8K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)Palodex Group OY20240—
+8K223816Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica20230—
+8K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephFona S.R.L20220—
+8K201140AxeosDentsply Sirona20201—
+8K183475T1-CS, T1-COsstem Implant Co., Ltd.201921
+8K191616Orthophos SDentsply Sirona20190—
+8K181983PreXion 3D ExcelsiorPrexion Corporation20180—
+8K181432ProVectra 3D Prime with VistaSoftDurr Dental SE20181—
+8K161131FONA Pan/CephFona S.R.L20160—
+8K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd.201619—
+9K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.20260—
+9K253959Primevision 3DDentsply Sirona20260—
+9K212303T2Osstem Implant Co., Ltd.202111
+9K200270rainbow MCTDentium Co., Ltd (Ict Branch)20210—
+9K170066Green16/Green18 (Model: PHT-65LHS)VATECH Co., Ltd.201718—
+10K233806T2 PlusOsstem Implant Co., Ltd.202401
+10K203797vatech A9 (Model : PHT-30CSS)VATECH Co., Ltd.20210—
+10K201627Dental Computed Tomography X-Ray System, Green XVATECH Co., Ltd.20205—
+10K181452RCT800Ray Co., Ltd.201810—
+11K231796Grreen X 12 (Model: PHT-75CHS)VATECH Co., Ltd.20232—
+11K210329Green X 18(Model : PHT-75CHS)VATECH Co., Ltd.20212—
+11K182805RCT800Ray Co., Ltd.20188—
+11K182614RCT700Ray Co., Ltd.20186—
+12K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.20260—
+12K243088Green X 12 SE (PHT-40CHS)VATECH Co., Ltd.20250—
+12K243081Green X 21 (PHT-90CHO)VATECH Co., Ltd.20251—
+12K213226RCT700Ray Co., Ltd.20215—
+12K192737RCT800Ray Co., Ltd.20197—
+13K251798RCT700Ray Co., Ltd.20250—
+13K243903RCT600Ray Co., Ltd.20250—
+13K242805Dental Cone-beam Computed Tomography (FinScan F350)Changzhou Finno Medical Technology Co., Ltd.20250—
+13K230753RCT800Ray Co., Ltd.20231—
+13K222219R2 Studio Q/RCT820Megagen Implant Co., Ltd.20220—
+14K260462RCT800Ray Co., Ltd.20260—