510(k) Report

Devices descending from K911752

849 later devices reach Icon Teleradiology System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K182130iSchemaView RAPIDIschemaview, Inc.20189—
+11K183037Monaco RTP SystemElekta, Inc.201856
+11K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+11K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+11K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+11K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+11K170580Carestream Vue PACSCarestream Health, Inc.20171—
+11K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+11K142647mint LesionMint Medical GmbH201523
+12K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+12K253794Prostate CoreLucida Medical, Ltd.20260—
+12K260528OncoStudioOncosoft. Inc.,20260—
+12K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+12K253689syngo Dynamics (VA41F)Siemens Healthcare GmbH20260—
+12K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+12K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+12K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+12K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+12K250696AccuCheckManteia Technologies Co., Ltd.20250—
+12K252539Tempus PixelArterys, Inc.20250—
+12K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+12K251747VEA Align; spineEOSEos Imaging20251—
+12K251629UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic)20251—
+12K251096PeekMed webPeek Health, S.A.20253—
+12K251766TumorSight VizSimBioSys, Inc.20250—
+12K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+12K241975Serv Medical CDSSServ Medical Pte., Ltd.20250—
+12K242123Brainomix 360 e-CTABrainomix Limited20250—
+12K243447Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd.20240—
+12K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+12K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+12K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+12K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+12K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+12K231570StrokeViewer PerfusionNico-Lab B.V.20230—
+12K230016Cercare Medical NeurosuiteCercare Medical A/S20232—
+12K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC20230—
+12K213986CerebralGo PlusYukun (Beijing) Technology Co., Ltd.20230—
+12K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+12K230294CoverScan (CoverScan v1.1)Perspectum20230—
+12K223229MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB202304
+12K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+12K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+12K213165RapidIschemaview, Inc.20227—
+12K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.20221—
+12K211760Panther OISProwess, Inc.20210—
+12K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+12K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+12K202229AI MetricsAi Metrics, LLC20200—
+12K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+12K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+12K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+12K200899Quantib AI NodeQuantib B.V.20200—
+12K200487RayCare 3.1RaySearch Laboratories AB (PUBL)202015
+12K200935Mazor XMazor Robotics, Ltd.202015—
+12K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+12K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+12K190178Monaco RTP SystemElekta, Inc.201945
+12K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+12K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+13K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+13K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+13K252571mdprostateMediaire GmbH20260—
+13K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+13K253690LungMapsSiemens Healthineers AG20260—
+13K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.20260—
+13K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+13K261289UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic)20260—
+13K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+13K252856PeekMed webPeek Health, S.A.20251—
+13K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+13K251078AutoDensityEos Imaging20250—
+13K252452PeekMed webPeek Health, S.A.20250—
+13K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+13K252526Rapid DeltaFuseIschemaview, Inc.20250—
+13K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+13K242992RayCare (2024A SP1)RaySearch Laboratories AB (PUBL)202502
+13K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+13K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+13K241989Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/S20241—
+13K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+13K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+13K233582RapidIschemaview, Inc.20243—
+13K233512Rapid (6.0)Ischemaview, Inc.20241—
+13K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+13K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+13K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+13K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+13K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+13K202789Monaco Rtp SystemElekta Solutions AB20213—
+13K203005Mazor XMazor Robotics, Ltd.2020141
+13K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+13K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+14K261368Rapid Platform (R6.7)Ischemaview, Inc.20260—
+14K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.20260—
+14K261306AI Contouring (VA10A)Varian Medical Systems20260—
+14K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+14K253831CMN Capillary Function with Virtual Expert for MRI, CT and CBCTCercare Medical A/S20260—
+14K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+14K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—