510(k) Report

Devices descending from K993037

330 later devices reach LCV+ Version 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252503Intelligent NRCanon, Inc.20260—
+5K243884TavipilotCaranx Medical20250—
+5K242488Soteria E-ViewOmega Medical Imaging, LLC20250—
+5K230985Planmeca VisoPlanmeca Oy20233—
+5K221335D²RS and D²RS 9090Stephanix20220—
+5K203010Platinum dRF Imaging SystemApelem-Dms Group20210—
+5K200965XR-MX/1000Karl Storz Endoscopy America, Inc.20200—
+5K202235ArtPIX DRFCmt Medical Technologies, Ltd.20200—
+5K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+5K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+5K182546Alphenix, INFX-8000H/B, V8.0Canon Medical Systems Corporation201802
+5K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.20181359
+5K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+5K181080McKesson CardiologyChange Healthcare Israel, Ltd.20181—
+5K180651Uroview FD IIPausch Medical GmbH20180—
+5K163286ARTIS phenoSiemens Medical Solution USA, Inc.20172314
+5K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+5K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+5K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+5K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+5K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+5K152697Infx-8000C, V6.20Toshibamedical Systems Corporation201635
+5K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+5K151485GenesisDornier Medtech America, Inc.20151—
+5K150663Diagnostic X-ray SystemOsko, Inc.20150—
+5K143361Mammo WorkstationGE Healthcare20151—
+5K143281Ultimax-iToshibamedical Systems Corporation20150—
+5K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation20152—
+5K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+5K133434Genesis IIDornier Medtech America, Inc.20142—
+5K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation20143—
+5K141574Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc.20141412
+5K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+5K133580Artis OneSiemens Medical Solutions USA, Inc.2014117
+5K133278Discovery Igs 740GE Medical Systems SCS201445
+5K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+5K132558Sync-RX SystemVolcano Corporation201331
+5K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+5K130842Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura…Philips Medical Systems Nederland B.V.20130Class I
+5K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+5K123922Syngo DynamicsSiemens Medical Solutions USA, Inc.20135—
+5K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+5K120514CardiopacsLumedx20120—
+5K092713Spectre Wireless Encrypted Footswitch and Hand Switch SystemTransamerican Medical Imaging201001
+5K082907IC-Pro System, Version 3.1.0.4Paieon, Inc.200836—
+5K062650EP Navigator SoftwarePhilips Medical Systems200649—
+6K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+6K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+6K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.20260—
+6K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+6K2434463DXRGE Medical Systems SCS20250—
+6K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+6K233230See Factor CT3™Epica International, Inc.20240—
+6K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+6K223550DMXDel Medical, Inc.20230—
+6K221516ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc.202233
+6K220871NautilusDornier Medtech America, Inc.20220—
+6K212528Change Healthcare CardiologyChange Healthcare Israel, Ltd.20210—
+6K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+6K201156ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.202056
+6K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+6K190768ARTIS iconoSiemens Medical Solutions USA, Inc.2019104
+6K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+6K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+6K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+6K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA20181—
+6K181804Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation201823
+6K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+6K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+6K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+6K171053syngo Dynamics Version VA30Siemens Healthcare GmbH20174—
+6K163622Lung VisionBodyvision Medical, Ltd.20176—
+6K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+6K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+6K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+6K160937SenolrisGE Healthcare20160—
+6K151904SyncVision SystemVolcano Corporation201521
+6K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation201592
+6K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation20147—
+6K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+6K100849Sync-RX System, Model AS00010Sync-Rx, Ltd.20104—
+6K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+7K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+7K251199Allia MoveoGE Medical Systems SCS202501
+7K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+7K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+7K233543YSIO X.preeSiemens Medical Solutions20241—
+7K231995AcuityUDRRadmedix, LLC20230—
+7K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc.202244
+7K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+7K220832syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc.20223—
+7K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+7K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation202117
+7K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—