510(k) Report

Devices descending from K103659

16 later devices reach CS 9300, CS 9300C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161881PreXion3D ExcelsiorPrexion Corporation20162—
+1K160506Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy20167—
+1K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd.20136—
+1K120948Prexion 3DThe Yoshida Dental Mfg. Co., Ltd.20120—
+2K181576Planmeca VisoPlanmeca Oy20184—
+2K181136CS 9600Trophy201811
+2K173878PreXion3D ExcelsiorPrexion Corporation20181—
+2K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp.20162—
+3K230985Planmeca VisoPlanmeca Oy20233—
+3K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica20211—
+3K200183CS 9600Trophy202001
+3K181983PreXion 3D ExcelsiorPrexion Corporation20180—
+4K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+4K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+4K223816Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica20230—
+5K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—