510(k) Report

Devices descending from K012490

33 later devices reach Orion Digital Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093066I5 Digital X-Ray Imaging System, Model I5Infimed, Inc.201022—
+1K070390Fluoropro RF Digital Imaging SystemVirtual Imaging, Inc.20073—
+1K061173Cpivision Digital Imaging SystemCommunications & Power Industries Canada, Inc.20061—
+1K053029NDR+/Diva-DNical Spa20063—
+2K191310Insight Essentials DRF Digital Imaging SystemImaging Engineering, LLC20192—
+2K162529DigiX FDXAllengers Medical Systems Limited20176—
+2K122726Cpi Rad VisionCommunications & Power Industries Canada, Inc.20130—
+2K112180I5 Digital X-Ray Imaging System (with SDX-4336CP)Infimed, Inc.20110—
+2K103416Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc.201117—
+2K101833Infistitch for I5 Digital X-Ray Imaging System, Model I5Infimed, Inc.20101—
+2K080847Rfvision, Model 9.9DAlmana Medical Imaging20080—
+2K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+3K200396Insight Enhanced DRF Digital Imaging SystemImaging Engineering, LLC20201—
+3K192541DigiX FDXAllengers Medical Systems Limited20195—
+3K130318Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Varian Medical Systems, X-Ray Products-Infimed201315—
+3K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+3K111344I5 Digital X-Ray Imaging System (with Flaatz 560)Infimed, Inc.20110—
+3K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+4K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging Corporation20260—
+4K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC20250—
+4K223060DigiX FDXAllengers Medical Systems Limited20224—
+4K202235ArtPIX DRFCmt Medical Technologies, Ltd.20200—
+4K191504PowerDRRadiology Information Systems, Inc.20190—
+4K161459Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)Varian Medical Systems, X-Ray Products-Infimed20165—
+5K230985Planmeca VisoPlanmeca Oy20233—
+5K183212Nexus DR Digital X-ray Imaging System with stitchingVarex Imaging Corporation20182—
+5K171138Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation20174—
+6K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+6K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+6K190146Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation20191—
+6K172951Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)Varex Imaging Corporation20173—
+7K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+7K193238Nexus DR Digital X-Ray Imaging System (with vSharp)Varex Imaging Corporation20190—