510(k) Report

Devices descending from K010721

248 later devices reach Axiom Artis Modular Angiography System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K200218Digiscan FDXAllengers Medical Systems Limited20201—
+5K201172CFP-3131, CFP-2222Mx Imaging, Inc.20200—
+5K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+5K200887AS-10Canon, Inc.20200—
+5K183144uMC 560iShanghai United Imaging Healthcare Co., Ltd.20190—
+5K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…Omega Medical Imaging, LLC20190—
+5K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+5K182415Alphenix, INFX-8000F/B, V8.0Canon Medical Systems Corporation201805
+5K181767Cios SelectSiemens Medical Solutions USA, Inc.20185—
+5K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.20181359
+5K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+5K180651Uroview FD IIPausch Medical GmbH20180—
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+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—
+5K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+5K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+5K151485GenesisDornier Medtech America, Inc.20151—
+5K150663Diagnostic X-ray SystemOsko, Inc.20150—
+5K143281Ultimax-iToshibamedical Systems Corporation20150—
+5K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+5K133434Genesis IIDornier Medtech America, Inc.20142—
+5K141574Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc.20141412
+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
+5K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+5K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+5K120073Infx-8000V withToshibamedical Systems Corporation2012203
+5K113052Infinix-CciToshiba America Medical Systems, In.C201171
+5K112054Infinix CF-I/SP and Infinix VF-I/SP Model Infx-8000VToshiba Medical Systems Corporation, Japan20110—
+5K082830Infx-8000H, Infinix-IToshiba America Medical Systems, In.C200812
+6K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+6K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+6K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+6K252503Intelligent NRCanon, 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—
+6K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+6K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+6K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+6K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+6K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+6K242488Soteria E-ViewOmega Medical Imaging, LLC20250—
+6K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+6K233230See Factor CT3™Epica International, Inc.20240—
+6K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+6K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+6K223550DMXDel Medical, Inc.20230—
+6K221516ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc.202233
+6K221335D²RS and D²RS 9090Stephanix20220—
+6K220871NautilusDornier Medtech America, Inc.20220—
+6K210307Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc.20211—
+6K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+6K201156ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.202056
+6K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+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—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+6K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+6K182546Alphenix, INFX-8000H/B, V8.0Canon Medical Systems Corporation201802
+6K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+6K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+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—
+6K152697Infx-8000C, V6.20Toshibamedical Systems Corporation201635
+6K151904SyncVision SystemVolcano Corporation201521
+6K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation20152—
+6K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation20143—
+6K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+6K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+7K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+7K2434463DXRGE Medical Systems SCS20250—
+7K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+7K233543YSIO X.preeSiemens Medical Solutions20241—
+7K231995AcuityUDRRadmedix, LLC20230—
+7K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+7K223409Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc.20220—
+7K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc.202244
+7K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+7K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+7K193326ARTIS IconoSiemens Medical Solutions USA, Inc.2020013
+7K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+7K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+7K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+7K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+7K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA20181—
+7K181804Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation201823
+7K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I