510(k) Report

Devices descending from K140825

7 later devices reach Delworks DR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162529DigiX FDXAllengers Medical Systems Limited20176—
+2K192541DigiX FDXAllengers Medical Systems Limited20195—
+3K223060DigiX FDXAllengers Medical Systems Limited20224—
+4K230985Planmeca VisoPlanmeca Oy20233—
+5K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+5K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+6K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—