510(k) Report

Devices descending from K982862

463 later devices reach Radworks Medical Imaging Software with Quality Control Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K243069Lumys (V1)Intradys20250—
+8K243697MySpine WebPlannerMedacta International S.A.20250—
+8K243769QFR (3.0)Qfr Solutions BV20250—
+8K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+8K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+8K240926PeekMed webPeek Health, S.A.20246—
+8K242709JLK-PwiJLK, Inc.20240—
+8K242556JLK-CTPJLK, Inc.20240—
+8K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+8K240172Preview ShoulderGenesis Software Innovations20240—
+8K240284Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex…Shenzhen Browiner Tech Co., Ltd.20240—
+8K233421Rescan 700Carl Zeiss Meditec, AG20240—
+8K231662Aid-UIaid20241—
+8K231130TumorSight VizSimBioSys, Inc.20232—
+8K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+8K232086spineEOSEos Imaging20235—
+8K230249IkshanaImmersivetouch20231—
+8K231656Brainomix 360 e-MRIBrainomix Limited20230—
+8K223555Brainomix 360 e-CTPBrainomix Limited20230—
+8K221870CarnaLife HoloMedapp S.A.20230—
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K213891RealNowYiwei Medical Technology Co., Ltd.20230—
+8K213215VSI HoloMedicineApoqlar GmbH20222—
+8K220663AccuCTPArteryFlow Technology Co., Ltd.20221—
+8K222428Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc.20222—
+8K213779Customize3D-Side S.A.20221—
+8K210670BU-CADTaihao Medical, Inc.20213—
+8K212137X-CleverLg Electronics.Inc20211—
+8K212515MOVIX DReamyStephanix20210—
+8K212291PhoenixSedecal., Sa.202141
+8K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+8K212134Diagnostic X-ray System/PLX5200ANanjing Perlove Medical Equipment Co., Ltd.20210—
+8K2029022430MCA with Xmaru WRayence Co., Ltd.20211—
+8K203703I-Q ViewFirst Source, Inc.20210—
+8K202487HealthJOINTZebra Medical Vision, Ltd.20200—
+8K192912AutoMIStarApollo Medical Imaging Technology Pty., Ltd.20190—
+8K192936Soltus 500Sedecal., Sa.201901
+8K192541DigiX FDXAllengers Medical Systems Limited20195—
+8K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+8K191451CMDR 2CW (Multiple models)Minxray, Inc.201911—
+8K173771IOLMaster 700Carl Zeiss Meditec, AG201811
+8K180307Mazor XMazor Robotics, Ltd.201817—
+8K173390hipEOSOnefit Medical20188—
+8K180161Viz CTPViz. Ai, Inc.20182—
+8K172477iSchemaView RAPIDIschemaview, Inc.201817—
+8K180091UNiD Spine AnalyzerMedicrea International20186—
+8K173247Surgical Planning Software version 1.1Ortho Kinematics, Inc.20170—
+8K172522Mazor XMazor Robotics, Ltd.20170—
+8K161601DynamikaImage Analysis Limited20170—
+8K170930RSM 2430CDRTECH Corporation20171—
+8K152602Olea Sphere V3.0Olea Medical201617—
+9K260086CadAI-B DxBeamWorks, Inc.20260—
+9K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+9K251577Laia XRAugmented Reality Software S.L.20260—
+9K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+9K250039HPACSHealthhub20250—
+9K250290SurgiTwinTwinsight20250—
+9K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+9K242551syngo Dynamics (Version VA41D)Siemens Healthcare GmbH20251—
+9K250042PeekMed webPeek Health, S.A.20254—
+9K2438492430TCA with Xmaru WRayence Co., Ltd.20250—
+9K241113Vivix-MVieworks Co., Ltd.20250—
+9K243189TumorSight VizSimBioSys, Inc.20241—
+9K240094LumiNE US; LumiAugmedit B.V.20240—
+9K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+9K240582VEA Align; spineEOSEos Imaging20244—
+9K233599X-Clever (ASHK100G)Lg Electronics.Inc20240—
+9K231353AccuCTP ProArteryFlow Technology Co., Ltd.20230—
+9K232185SM-IVSedecal., Sa.20230—
+9K223091CT Perfusion V1.0Olea Medical20230—
+9K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—
+9K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+9K211059CereFlow™ V1.2Translational Mri, LLC20231—
+9K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+9K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+9K221627PerfusionGo PlusYukun (Beijing) Technology Co., Ltd.20230—
+9K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+9K222951SM-VSedecal., Sa.20221—
+9K223060DigiX FDXAllengers Medical Systems Limited20224—
+9K221432Customize3D-Side S.A.20220—
+9K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.Sedecal., Sa.202201
+9K212565CoverScan v1Perspectum, Ltd.20221—
+9K212040RI.Hip ModelerBlue Belt Technologies, Inc.20223—
+9K212005UNiD Spine AnalyzerMedicrea International, Inc.202221
+9K202793Cercare Medical NeurosuiteCercare Medical Aps20213—
+9K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+9K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+9K192692Brainomix 360 e-CTABrainomix Limited20203—
+9K200726AcuityPDRRadmedix, LLC20209—
+9K192962icobrain-ctpIcometrix NV20200—
+9K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+9K182130iSchemaView RAPIDIschemaview, Inc.20189—
+9K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+9K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+9K170580Carestream Vue PACSCarestream Health, Inc.20171—
+10K253794Prostate CoreLucida Medical, Ltd.20260—
+10K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—