510(k) Report

Devices descending from K090171

59 later devices reach Computed Tomography X-Ray System, Pax-REVE3D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102259Dental Computed Tomography X-Ray SystemVATECH Co., Ltd.201142—
+1K102124Dental Computed Tomography X-Ray SystemVATECH Co., Ltd.201015—
+2K120263Volux 21C, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd.201214—
+2K121412Pax-FLEX3D, PHT-7000VATECH Co., Ltd.201228—
+2K113672PCH-2500 Digital Extraoral Source X-Ray SystemVATECH Co., Ltd.201212—
+3K123070Galileos FamilySirona Dental Systems GmbH201313—
+3K122606PHT-6500; PHT-60CFO; Pax-I3DMtechgroup201227—
+3K122155PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source X-Ray SystemVATECH Co., Ltd.201211—
+4K170731System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i InsightVATECH Co., Ltd.20171—
+4K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International20162—
+4K152106Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd.201525—
+4K150217Orthophos SLSirona Dental Systems GmbH20155—
+4K133620Cone Beam 3D and 2D Panoramic Dental Imaging SystemImaging Sciences International20146—
+4K130419Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd.20137—
+4K130585PCH-2500 Digital Extraoral Source X-Ray System, Pax-I Digital Extraoral Source X-Ray…VATECH Co., Ltd.20130—
+4K130432PHT-6500, PHT-60CFOVATECH Co., Ltd.20130—
+5K243337Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.20251—
+5K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan…VATECH Co., Ltd.20240—
+5K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephFona S.R.L20220—
+5K201140AxeosDentsply Sirona20201—
+5K183475T1-CS, T1-COsstem Implant Co., Ltd.201921
+5K191616Orthophos SDentsply Sirona20190—
+5K181432ProVectra 3D Prime with VistaSoftDurr Dental SE20181—
+5K161131FONA Pan/CephFona S.R.L20160—
+5K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd.201619—
+5K161881PreXion3D ExcelsiorPrexion Corporation20162—
+5K141700Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd.20146—
+6K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.20260—
+6K253959Primevision 3DDentsply Sirona20260—
+6K220423PAPAYA & PAPAYA PlusGenoray Co., Ltd.20220—
+6K212303T2Osstem Implant Co., Ltd.202111
+6K200270rainbow MCTDentium Co., Ltd (Ict Branch)20210—
+6K173878PreXion3D ExcelsiorPrexion Corporation20181—
+6K170066Green16/Green18 (Model: PHT-65LHS)VATECH Co., Ltd.201718—
+6K150354PAPAYA 3D PlusGenoray Co., Ltd.20154—
+7K233806T2 PlusOsstem Implant Co., Ltd.202401
+7K220392PAPAYA 3D & PAPAYA 3D PlusGenoray Co., Ltd.20220—
+7K203797vatech A9 (Model : PHT-30CSS)VATECH Co., Ltd.20210—
+7K201627Dental Computed Tomography X-Ray System, Green XVATECH Co., Ltd.20205—
+7K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd.20201—
+7K181983PreXion 3D ExcelsiorPrexion Corporation20180—
+7K181452RCT800Ray Co., Ltd.201810—
+7K151137X-View, ImagenEdlen Imaging, LLC20160—
+8K250060GT300; GT300-CGenoray Co., Ltd.20250—
+8K231796Grreen X 12 (Model: PHT-75CHS)VATECH Co., Ltd.20232—
+8K210329Green X 18(Model : PHT-75CHS)VATECH Co., Ltd.20212—
+8K182805RCT800Ray Co., Ltd.20188—
+8K182614RCT700Ray Co., Ltd.20186—
+9K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.20260—
+9K243088Green X 12 SE (PHT-40CHS)VATECH Co., Ltd.20250—
+9K243081Green X 21 (PHT-90CHO)VATECH Co., Ltd.20251—
+9K213226RCT700Ray Co., Ltd.20215—
+9K192737RCT800Ray Co., Ltd.20197—
+10K251798RCT700Ray Co., Ltd.20250—
+10K243903RCT600Ray Co., Ltd.20250—
+10K242805Dental Cone-beam Computed Tomography (FinScan F350)Changzhou Finno Medical Technology Co., Ltd.20250—
+10K230753RCT800Ray Co., Ltd.20231—
+10K222219R2 Studio Q/RCT820Megagen Implant Co., Ltd.20220—
+11K260462RCT800Ray Co., Ltd.20260—