510(k) Report

Devices descending from K063283

14 later devices reach Definium 5000 X-Ray System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122495Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorPerkinelmer, Inc.201213—
+2K140551Perkinelmer, Xrpad 4336 Med Flat Panel DetectorPerkinelmer, Inc.201412—
+3K162529DigiX FDXAllengers Medical Systems Limited20176—
+3K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorPerkinelmer, Inc.20161—
+3K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel DetectorPerkinelmer, Inc.20160—
+3K151221Kubtec DIGIVIEW 395Kub Technologies, Inc.20150—
+3K142698PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc.20147—
+4K192541DigiX FDXAllengers Medical Systems Limited20195—
+4K181526XRpad2 4343 HWC-M Flat Panel DetectorVarex Imaging Corporation20180—
+5K223060DigiX FDXAllengers Medical Systems Limited20224—
+6K230985Planmeca VisoPlanmeca Oy20233—
+7K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+7K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+8K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—