510(k) Report

Devices descending from K160506

7 later devices reach Planmeca ProMax 3D Max, Planmeca Maximity through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181576Planmeca VisoPlanmeca Oy20184—
+1K181136CS 9600Trophy201811
+2K230985Planmeca VisoPlanmeca Oy20233—
+2K200183CS 9600Trophy202001
+3K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+3K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+4K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—