510(k) Report

Devices descending from K033248

18 later devices reach Hitachi CB Mercuray Dental Cone-Beam X-Ray System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092171Volux, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd.20100—
+1K060892GalileosSirona Dental Systems GmbH200617—
+2K123070Galileos FamilySirona Dental Systems GmbH201313—
+2K103711Orthophos XG 3D / CephSirona Dental Systems GmbH20117—
+3K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International20162—
+3K150217Orthophos SLSirona Dental Systems GmbH20155—
+3K133797Qmaster-H/RevoTelesystems Co., Ltd.20140—
+3K133620Cone Beam 3D and 2D Panoramic Dental Imaging SystemImaging Sciences International20146—
+4K243337Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.20251—
+4K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephFona S.R.L20220—
+4K201140AxeosDentsply Sirona20201—
+4K191616Orthophos SDentsply Sirona20190—
+4K161131FONA Pan/CephFona S.R.L20160—
+4K161881PreXion3D ExcelsiorPrexion Corporation20162—
+5K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.20260—
+5K253959Primevision 3DDentsply Sirona20260—
+5K173878PreXion3D ExcelsiorPrexion Corporation20181—
+6K181983PreXion 3D ExcelsiorPrexion Corporation20180—