510(k) Report

Devices descending from K111152

27 later devices reach Rotograph Evo 3D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130443I-Max Touch 3DOwandy201321
+1K122981Rayscan a-Expert 3DRay Co., Ltd.201324—
+2K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark…Villa Sistemi Medicali S.P.A.20181—
+2K160525RCT700Ray Co., Ltd.201611—
+2K142247Rayscan a-Expert 3DRay Co., Ltd.201522—
+2K131695Rayscan a-Expert 3DRay Co., Ltd.201323—
+3K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L.20200—
+3K182614RCT700Ray Co., Ltd.20186—
+3K181452RCT800Ray Co., Ltd.201810—
+3K160140DENTRIa seriesHdx Will Corp.20169—
+4K230985Planmeca VisoPlanmeca Oy20233—
+4K211159eco-x Series (eco-x, eco-x-s)Hdx Will Corp.20210—
+4K213226RCT700Ray Co., Ltd.20215—
+4K212254DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Hdx Will Corp.20211—
+4K182805RCT800Ray Co., Ltd.20188—
+4K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp.20181—
+5K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+5K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.20260—
+5K251798RCT700Ray Co., Ltd.20250—
+5K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+5K243903RCT600Ray Co., Ltd.20250—
+5K242805Dental Cone-beam Computed Tomography (FinScan F350)Changzhou Finno Medical Technology Co., Ltd.20250—
+5K230753RCT800Ray Co., Ltd.20231—
+5K192737RCT800Ray Co., Ltd.20197—
+6K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+6K260462RCT800Ray Co., Ltd.20260—
+6K222219R2 Studio Q/RCT820Megagen Implant Co., Ltd.20220—