510(k) Report

Devices descending from K913770

1,148 later devices reach Advantage V.S. CT/MR Rad Diagnostic Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K1619555D ViewerSamsung Medison Co., Ltd.20163—
+8K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+8K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+8K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+8K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+8K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+8K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+8K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc.20151—
+8K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+8K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+8K15100721.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)Jvckenwood Corporation20150—
+8K143361Mammo WorkstationGE Healthcare20151—
+8K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+8K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+8K143718Mammography Color Display DP-M3010Canon, Inc.20150—
+8K141855ClarityElekta, Ltd.20140—
+8K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+8K1407028MP Color LCD Monitor, Radiforce RX850Eizo Corporation201401
+8K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+8K13368621.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)Jvckenwood Corporation20141—
+8K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+8K121213VitreaadvancedVital Images, Inc.201281
+8K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+8K121023Spectrum V.0Intrinsic Medical Imaging20120—
+8K120207VISIAMeVis Medical Solutions AG20120—
+8K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+8K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+8K11344321.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd.20112—
+8K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+8K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+8K083691BonevueMicromri, Inc.20090—
+8K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+8K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+8K072821Vitrea 4DCTVital Images, Inc.2008171
+9K260597Virtue QAProNova Solutions20260—
+9K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+9K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+9K254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+9K260166Bunkerhill Contrast CACBunkerHill Health20260—
+9K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+9K252500CARA SystemCara Medical, Ltd.20260—
+9K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+9K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+9K251355X1-FFRSpectrawave, Inc.20250—
+9K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+9K250662Bunkerhill MACBunkerHill Health20250—
+9K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+9K252539Tempus PixelArterys, Inc.20250—
+9K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+9K250181AV ViewerPhilips Medical Systems Nederland B.V.20251—
+9K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+9K243069Lumys (V1)Intradys20250—
+9K250416GBrain MRIGalileo Cds, Inc.20251—
+9K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+9K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+9K243614Sonio SuspectSonio20251—
+9K243229Bunkerhill AVCBunkerHill Health20253—
+9K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+9K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+9K242130Koios DSKoios Medical, Inc.20241—
+9K242342Fetal EchoScanBrightheart20242—
+9K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+9K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+9K241245EchoSolv ASEcho IQ, Ltd.20240—
+9K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+9K240791ADAS 3DAdas3D Medical S.L.20241—
+9K233998TRAQinform IQAiq Global, Inc.20240—
+9K241302SonoSyncSamsung Medison Co., Ltd.20240—
+9K234141AISAP Cardio V1.0Aisap20240—
+9K240281Bone Suppression SoftwareKonica Minolta, Inc.20240—
+9K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+9K232147CAAS WorkstationPie Medical Imaging BV20241—
+9K232479ART-PlanTherapanacea20232—
+9K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+9K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+9K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+9K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+9K230575Limbus ContourLimbus Ai, Inc.20231—
+9K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+9K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+9K222275Saige-DensityDeepHealth, Inc.20221—
+9K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+9K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+9K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+9K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+9K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+9K213787Monaco RTP SystemElekta Solutions AB20222—
+9K220767TeleScanBb Imaging20221—
+9K213976Contour ProtégéAIMim Software, Inc.20224—
+9K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+9K212887RTappSegana, Inc.20210—
+9K212383EndoNautTherenva Sas20212—
+9K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—
+9K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+9K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+9K203235VBrainVysioneer, Inc.20214—
+9K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+9K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+9K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+9K191928AccuContourXiamen Manteia Technology, Ltd.202030—