510(k) Report

Devices descending from K002432

32 later devices reach Strato X through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083057I-Max TouchOwandy20090—
+1K090749Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191Villa Sistemi Medicali S.P.A.200930—
+2K203374X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)De Götzen S.R.L.20210—
+2K162190Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark…Villa Sistemi Medicali S.P.A.20172—
+2K111152Rotograph Evo 3DVilla Sistemi Medicali S.P.A.2011271
+3K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark…Villa Sistemi Medicali S.P.A.20181—
+3K130443I-Max Touch 3DOwandy201321
+3K122981Rayscan a-Expert 3DRay Co., Ltd.201324—
+4K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L.20200—
+4K160525RCT700Ray Co., Ltd.201611—
+4K142247Rayscan a-Expert 3DRay Co., Ltd.201522—
+4K131695Rayscan a-Expert 3DRay Co., Ltd.201323—
+5K182614RCT700Ray Co., Ltd.20186—
+5K181452RCT800Ray Co., Ltd.201810—
+5K160140DENTRIa seriesHdx Will Corp.20169—
+6K230985Planmeca VisoPlanmeca Oy20233—
+6K211159eco-x Series (eco-x, eco-x-s)Hdx Will Corp.20210—
+6K213226RCT700Ray Co., Ltd.20215—
+6K212254DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Hdx Will Corp.20211—
+6K182805RCT800Ray Co., Ltd.20188—
+6K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp.20181—
+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—
+7K251798RCT700Ray Co., Ltd.20250—
+7K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+7K243903RCT600Ray Co., Ltd.20250—
+7K242805Dental Cone-beam Computed Tomography (FinScan F350)Changzhou Finno Medical Technology Co., Ltd.20250—
+7K230753RCT800Ray Co., Ltd.20231—
+7K192737RCT800Ray Co., Ltd.20197—
+8K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+8K260462RCT800Ray Co., Ltd.20260—
+8K222219R2 Studio Q/RCT820Megagen Implant Co., Ltd.20220—