510(k) Report

Devices descending from K981993

175 later devices reach Olympus Integrated Endosurgery System Endoalpha through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203010Platinum dRF Imaging SystemApelem-Dms Group20210—
+7K200965XR-MX/1000Karl Storz Endoscopy America, Inc.20200—
+7K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+7K202235ArtPIX DRFCmt Medical Technologies, Ltd.20200—
+7K201156ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.202056
+7K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+7K200887AS-10Canon, Inc.20200—
+7K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+7K190768ARTIS iconoSiemens Medical Solutions USA, Inc.2019104
+7K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+7K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+7K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+7K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+7K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+7K180651Uroview FD IIPausch Medical GmbH20180—
+7K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+7K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+7K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+7K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+7K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+7K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+7K151904SyncVision SystemVolcano Corporation201521
+7K151485GenesisDornier Medtech America, Inc.20151—
+7K133434Genesis IIDornier Medtech America, Inc.20142—
+7K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+8K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+8K252503Intelligent NRCanon, Inc.20260—
+8K2434463DXRGE Medical Systems SCS20250—
+8K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+8K233543YSIO X.preeSiemens Medical Solutions20241—
+8K231995AcuityUDRRadmedix, LLC20230—
+8K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+8K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc.202244
+8K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+8K221335D²RS and D²RS 9090Stephanix20220—
+8K220871NautilusDornier Medtech America, Inc.20220—
+8K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+8K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+8K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+8K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+8K193326ARTIS IconoSiemens Medical Solutions USA, Inc.2020013
+8K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+8K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+8K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+8K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+8K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+8K161756SyncVision SystemVolcano Corporation201611
+9K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+9K251199Allia MoveoGE Medical Systems SCS202501
+9K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+9K250738YSIO X.preeSiemens Medical Solutions20250—
+9K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+9K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+9K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+9K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+9K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+9K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+9K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+9K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+9K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+9K172574SyncVision SystemVolcano Corporation201701
+10K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+10K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+10K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+10K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+10K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+11K251827Azurion R3.1Philips Medical Systems B.V.20251—
+11K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+11K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+11K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+12K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+12K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+12K254186Azurion R3.1Philips Medical Systems B.V.20260—
+12K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+12K233532MULTIX Impact ESiemens Medical Solutions20230—