510(k) Report

Devices descending from K093066

22 later devices reach I5 Digital X-Ray Imaging System, Model I5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162529DigiX FDXAllengers Medical Systems Limited20176—
+1K122726Cpi Rad VisionCommunications & Power Industries Canada, Inc.20130—
+1K112180I5 Digital X-Ray Imaging System (with SDX-4336CP)Infimed, Inc.20110—
+1K103416Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc.201117—
+1K101833Infistitch for I5 Digital X-Ray Imaging System, Model I5Infimed, Inc.20101—
+2K192541DigiX FDXAllengers Medical Systems Limited20195—
+2K130318Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Varian Medical Systems, X-Ray Products-Infimed201315—
+2K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+2K111344I5 Digital X-Ray Imaging System (with Flaatz 560)Infimed, Inc.20110—
+3K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging Corporation20260—
+3K223060DigiX FDXAllengers Medical Systems Limited20224—
+3K191504PowerDRRadiology Information Systems, Inc.20190—
+3K161459Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)Varian Medical Systems, X-Ray Products-Infimed20165—
+4K230985Planmeca VisoPlanmeca Oy20233—
+4K183212Nexus DR Digital X-ray Imaging System with stitchingVarex Imaging Corporation20182—
+4K171138Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation20174—
+5K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+5K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+5K190146Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation20191—
+5K172951Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)Varex Imaging Corporation20173—
+6K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+6K193238Nexus DR Digital X-Ray Imaging System (with vSharp)Varex Imaging Corporation20190—