510(k) Report

Devices descending from K020995

321 later devices reach Efilm Workstation with Modules through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K2029022430MCA with Xmaru WRayence Co., Ltd.20211—
+6K203703I-Q ViewFirst Source, Inc.20210—
+6K202487HealthJOINTZebra Medical Vision, Ltd.20200—
+6K192912AutoMIStarApollo Medical Imaging Technology Pty., Ltd.20190—
+6K192936Soltus 500Sedecal., Sa.201901
+6K192541DigiX FDXAllengers Medical Systems Limited20195—
+6K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+6K191451CMDR 2CW (Multiple models)Minxray, Inc.201911—
+6K180307Mazor XMazor Robotics, Ltd.201817—
+6K173390hipEOSOnefit Medical20188—
+6K180161Viz CTPViz. Ai, Inc.20182—
+6K172477iSchemaView RAPIDIschemaview, Inc.201817—
+6K180091UNiD Spine AnalyzerMedicrea International20186—
+6K173247Surgical Planning Software version 1.1Ortho Kinematics, Inc.20170—
+6K172522Mazor XMazor Robotics, Ltd.20170—
+6K161601DynamikaImage Analysis Limited20170—
+6K170930RSM 2430CDRTECH Corporation20171—
+6K152602Olea Sphere V3.0Olea Medical201617—
+7K260086CadAI-B DxBeamWorks, Inc.20260—
+7K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K250039HPACSHealthhub20250—
+7K250290SurgiTwinTwinsight20250—
+7K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+7K250042PeekMed webPeek Health, S.A.20254—
+7K2438492430TCA with Xmaru WRayence Co., Ltd.20250—
+7K241113Vivix-MVieworks Co., Ltd.20250—
+7K243189TumorSight VizSimBioSys, Inc.20241—
+7K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+7K240582VEA Align; spineEOSEos Imaging20244—
+7K233599X-Clever (ASHK100G)Lg Electronics.Inc20240—
+7K231353AccuCTP ProArteryFlow Technology Co., Ltd.20230—
+7K232185SM-IVSedecal., Sa.20230—
+7K223091CT Perfusion V1.0Olea Medical20230—
+7K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—
+7K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+7K211059CereFlow™ V1.2Translational Mri, LLC20231—
+7K221627PerfusionGo PlusYukun (Beijing) Technology Co., Ltd.20230—
+7K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+7K222951SM-VSedecal., Sa.20221—
+7K223060DigiX FDXAllengers Medical Systems Limited20224—
+7K221432Customize3D-Side S.A.20220—
+7K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.Sedecal., Sa.202201
+7K212565CoverScan v1Perspectum, Ltd.20221—
+7K212040RI.Hip ModelerBlue Belt Technologies, Inc.20223—
+7K212005UNiD Spine AnalyzerMedicrea International, Inc.202221
+7K202793Cercare Medical NeurosuiteCercare Medical Aps20213—
+7K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+7K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+7K192692Brainomix 360 e-CTABrainomix Limited20203—
+7K200726AcuityPDRRadmedix, LLC20209—
+7K192962icobrain-ctpIcometrix NV20200—
+7K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+7K182130iSchemaView RAPIDIschemaview, Inc.20189—
+7K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+7K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+7K170580Carestream Vue PACSCarestream Health, Inc.20171—
+8K253794Prostate CoreLucida Medical, Ltd.20260—
+8K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+8K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+8K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+8K251747VEA Align; spineEOSEos Imaging20251—
+8K251629UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic)20251—
+8K251096PeekMed webPeek Health, S.A.20253—
+8K251766TumorSight VizSimBioSys, Inc.20250—
+8K241975Serv Medical CDSSServ Medical Pte., Ltd.20250—
+8K242123Brainomix 360 e-CTABrainomix Limited20250—
+8K243447Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd.20240—
+8K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+8K230985Planmeca VisoPlanmeca Oy20233—
+8K231570StrokeViewer PerfusionNico-Lab B.V.20230—
+8K231577MOBILETT ImpactSiemens Medical Solutions20230—
+8K230016Cercare Medical NeurosuiteCercare Medical A/S20232—
+8K213986CerebralGo PlusYukun (Beijing) Technology Co., Ltd.20230—
+8K230294CoverScan (CoverScan v1.1)Perspectum20230—
+8K213165RapidIschemaview, Inc.20227—
+8K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+8K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20202—
+8K201948AcroDTI VisualizerAcroviz, Inc.20200—
+8K200935Mazor XMazor Robotics, Ltd.202015—
+8K201058Accuvue+Radmedix, LLC20204—
+9K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+9K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.20260—
+9K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+9K261289UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic)20260—
+9K252856PeekMed webPeek Health, S.A.20251—
+9K251078AutoDensityEos Imaging20250—
+9K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+9K252452PeekMed webPeek Health, S.A.20250—
+9K252526Rapid DeltaFuseIschemaview, Inc.20250—
+9K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+9K240841Digital Radiography System (ManntiX B, ManntiX K)Shenzhen Browiner Tech Co., Ltd.20240—
+9K241989Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/S20241—
+9K233582RapidIschemaview, Inc.20243—
+9K233512Rapid (6.0)Ischemaview, Inc.20241—
+9K210919AcuityDReRadmedix, LLC20213—
+9K203005Mazor XMazor Robotics, Ltd.2020141
+10K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+10K261368Rapid Platform (R6.7)Ischemaview, Inc.20260—