510(k) Report

Devices descending from K102259

42 later devices reach Dental Computed Tomography X-Ray System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121412Pax-FLEX3D, PHT-7000VATECH Co., Ltd.201228—
+1K113672PCH-2500 Digital Extraoral Source X-Ray SystemVATECH Co., Ltd.201212—
+2K122606PHT-6500; PHT-60CFO; Pax-I3DMtechgroup201227—
+2K122155PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source X-Ray SystemVATECH Co., Ltd.201211—
+3K170731System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i InsightVATECH Co., Ltd.20171—
+3K152106Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd.201525—
+3K130419Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd.20137—
+3K130585PCH-2500 Digital Extraoral Source X-Ray System, Pax-I Digital Extraoral Source X-Ray…VATECH Co., Ltd.20130—
+3K130432PHT-6500, PHT-60CFOVATECH Co., Ltd.20130—
+4K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan…VATECH Co., Ltd.20240—
+4K183475T1-CS, T1-COsstem Implant Co., Ltd.201921
+4K181432ProVectra 3D Prime with VistaSoftDurr Dental SE20181—
+4K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd.201619—
+4K141700Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd.20146—
+5K220423PAPAYA & PAPAYA PlusGenoray Co., Ltd.20220—
+5K212303T2Osstem Implant Co., Ltd.202111
+5K200270rainbow MCTDentium Co., Ltd (Ict Branch)20210—
+5K170066Green16/Green18 (Model: PHT-65LHS)VATECH Co., Ltd.201718—
+5K150354PAPAYA 3D PlusGenoray Co., Ltd.20154—
+6K233806T2 PlusOsstem Implant Co., Ltd.202401
+6K220392PAPAYA 3D & PAPAYA 3D PlusGenoray Co., Ltd.20220—
+6K203797vatech A9 (Model : PHT-30CSS)VATECH Co., Ltd.20210—
+6K201627Dental Computed Tomography X-Ray System, Green XVATECH Co., Ltd.20205—
+6K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd.20201—
+6K181452RCT800Ray Co., Ltd.201810—
+6K151137X-View, ImagenEdlen Imaging, LLC20160—
+7K250060GT300; GT300-CGenoray Co., Ltd.20250—
+7K231796Grreen X 12 (Model: PHT-75CHS)VATECH Co., Ltd.20232—
+7K210329Green X 18(Model : PHT-75CHS)VATECH Co., Ltd.20212—
+7K182805RCT800Ray Co., Ltd.20188—
+7K182614RCT700Ray Co., Ltd.20186—
+8K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.20260—
+8K243088Green X 12 SE (PHT-40CHS)VATECH Co., Ltd.20250—
+8K243081Green X 21 (PHT-90CHO)VATECH Co., Ltd.20251—
+8K213226RCT700Ray Co., Ltd.20215—
+8K192737RCT800Ray Co., Ltd.20197—
+9K251798RCT700Ray Co., Ltd.20250—
+9K243903RCT600Ray Co., Ltd.20250—
+9K242805Dental Cone-beam Computed Tomography (FinScan F350)Changzhou Finno Medical Technology Co., Ltd.20250—
+9K230753RCT800Ray Co., Ltd.20231—
+9K222219R2 Studio Q/RCT820Megagen Implant Co., Ltd.20220—
+10K260462RCT800Ray Co., Ltd.20260—