510(k) Report

Devices descending from K924459

194 later devices reach Digiscan 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983732Thorax FD and Multix FDSiemens Medical Solutions USA, Inc.19991871
+1K955457Digiscan 2 PlusSiemens Medical Solutions USA, Inc.19960—
+1K955643Alara Imaging SystemDenoptix, Inc.19964—
+2K071546EOSBiospace Med200771
+2K071682Crystalview T-Series Computed Radiography System, Models T110 (with Eraser) and T100…Alara, Inc.20071—
+2K033577Uniscan, Pulmoscan, Pulmoscan Radiographic SystemsMedlink Imaging20050—
+2K013826Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc.2002818
+2K992794Stingray DR, Model 1Infimed, Inc.1999103—
+2K990049CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000 and 2000Digident, Ltd.19990—
+2K974619Scanaray/CD-Dent Advanced Computerized X-Ray SystemAfp Imaging Corp.19981—
+3K161459Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)Varian Medical Systems, X-Ray Products-Infimed20165—
+3K123740EOSEos Imaging201351
+3K120721EOSEos Imaging20126—
+3K102479Alara T210 Computed Radiography SystemAlara, Inc.20110—
+3K093066I5 Digital X-Ray Imaging System, Model I5Infimed, Inc.201022—
+3K052661Quix Digital Radiographic UpgradeEdge Medical Devices, Ltd.20060—
+3K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc.2006803
+3K024147Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc.200378—
+4K183212Nexus DR Digital X-ray Imaging System with stitchingVarex Imaging Corporation20182—
+4K171138Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation20174—
+4K162529DigiX FDXAllengers Medical Systems Limited20176—
+4K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+4K142773EOS SystemEos Imaging20154—
+4K122726Cpi Rad VisionCommunications & Power Industries Canada, Inc.20130—
+4K120020Vivix-SVieworks Co., Ltd.201230—
+4K112180I5 Digital X-Ray Imaging System (with SDX-4336CP)Infimed, Inc.20110—
+4K111312SanteviewSehyun Co., Ltd.20110—
+4K103416Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc.201117—
+4K101833Infistitch for I5 Digital X-Ray Imaging System, Model I5Infimed, Inc.20101—
+4K092669DX-D Imaging PackageAgfa Healthcare N.V.2009341
+4K083645Radstar Family, Models: Radstar 4343 & Variations5 Star Medical, Inc.20096—
+4K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+4K080614DR Vision Neo, DR Vision DouAlmana Medical Imaging20080—
+4K080742Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH20085—
+4K072766Pvmed DDR 2520 Digital Imaging SystemPortavision Medical20070—
+4K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+5K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+5K223060DigiX FDXAllengers Medical Systems Limited20224—
+5K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+5K192541DigiX FDXAllengers Medical Systems Limited20195—
+5K190146Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation20191—
+5K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+5K172951Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)Varex Imaging Corporation20173—
+5K152788EOS SystemEos Imaging20153—
+5K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+5K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+5K132847I2CIon Beam Applications S.A.201303
+5K131211Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH20133—
+5K130318Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Varian Medical Systems, X-Ray Products-Infimed201315—
+5K122736DX-D Imaging PackageAgfa Healthcare N.V.201325—
+5K122865Vivix-S WirelessVieworks Co., Ltd.201328—
+5K122866Vivix-S with VxvueVieworks Co., Ltd.201311—
+5K121095DX-D Imaging PackageAgfa Healthcare N.V.20123—
+5K121513Multix FusionSiemens Medical Solution2012324
+5K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+5K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+5K111344I5 Digital X-Ray Imaging System (with Flaatz 560)Infimed, Inc.20110—
+5K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+5K103597DX-D 100Agfa Healthcare N.V.201116
+5K103050DX-D 300Agfa Healthcare N.V.20108—
+5K101435Imix Panorad and SomaradImix Adr Finland OY20101—
+5K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+5K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+5K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+5K092653Verisuite and Verisuite-Particle, Version 1.8Medcom GmbH20093—
+5K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+5K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+6K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging Corporation20260—
+6K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+6K230985Planmeca VisoPlanmeca Oy20233—
+6K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+6K193238Nexus DR Digital X-Ray Imaging System (with vSharp)Varex Imaging Corporation20190—
+6K192079EOSedgeEos Imaging20192—
+6K191504PowerDRRadiology Information Systems, Inc.20190—
+6K191884DR 100sAgfa N.V.20190—
+6K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+6K181789VeriSuiteMedcom GmbH20180—
+6K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+6K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+6K162344Innolux RicInnolux Corporation20161—
+6K161019Uroview FDPausch Medical GmbH201621
+6K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+6K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+6K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+6K152894Vivix-S 1717NVieworks Co., Ltd.20169—
+6K152855Vivix-S 1012NVieworks Co., Ltd.20165—
+6K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+6K150929CareView 1500Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.201512—
+6K150663Diagnostic X-ray SystemOsko, Inc.20150—
+6K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+6K142184DX-D Imaging PackageAgfa Healthcare N.V.20142—
+6K141602DX-D Imaging PackageAgfa Healthcare N.V.20140—
+6K141440Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH20142—
+6K141192DR 400Agfa Healthcare N.V.20147—
+6K140771Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH201415—
+6K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+6K133914Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleMedcom GmbH20142—
+6K122768GenesisDornier Medtech America, Inc.20134—
+6K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+6K113855Panorad, Panorad SLImix Adr Finland OY20120—