510(k) Report

Devices descending from K012086

207 later devices reach Aquariusnet Server through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231662Aid-UIaid20241—
+5K223424Spine Auto ViewsGE Medical Systems SCS20230—
+5K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+5K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+5K220590aPROMISE XExini Diagnostics AB20220—
+5K213944HealthOSTNanoxai, Ltd.20221—
+5K212896Visible Patient SuiteVisible Patient, Sas20213—
+5K212777Collaboration LivePhilips Ultrasound, Inc.20211—
+5K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+5K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+5K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+5K191262aBSIExini Diagnostics AB20192—
+5K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+5K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+5K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+5K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+5K173444Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc.20181—
+5K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+5K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+5K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+5K132532Syngo.Plaza VB10ASiemens AG Healthcare2013811
+5K1134423DIShina Systems, Ltd.20120—
+6K250039HPACSHealthhub20250—
+6K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+6K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+6K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+6K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+6K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+6K243069Lumys (V1)Intradys20250—
+6K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+6K233998TRAQinform IQAiq Global, Inc.20240—
+6K241302SonoSyncSamsung Medison Co., Ltd.20240—
+6K241440HealthCCSngNano-X AI, Ltd.20240—
+6K233457RUSHutom, Inc.20240—
+6K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+6K233080HealthFLDNano-X AI, Ltd.20240—
+6K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+6K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+6K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+6K230112CAC SoftwareImbio, Inc.20230—
+6K230223iCAC DeviceBunkerhill, Inc.20236—
+6K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K201948AcroDTI VisualizerAcroviz, Inc.20200—
+6K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+6K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+6K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+6K180563syngo.plazaSiemens Healthcare GmbH20180—
+6K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+6K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+6K142750JiveXVisus Technology Transfer GmbH20156—
+7K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+7K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+7K260166Bunkerhill Contrast CACBunkerHill Health20260—
+7K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+7K250662Bunkerhill MACBunkerHill Health20250—
+7K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+7K243229Bunkerhill AVCBunkerHill Health20253—
+7K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+7K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+7K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+7K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+7K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+7K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+7K200132AshvinsMedicalcommunications GmbH202001
+7K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+7K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+7K162008JiveXVisus Technology Transfer GmbH20164—
+8K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+8K252571mdprostateMediaire GmbH20260—
+8K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+8K253690LungMapsSiemens Healthineers AG20260—
+8K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+8K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+8K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+8K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+8K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+8K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+8K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+8K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+8K181964JiveXVisus Health IT GmbH20183—
+9K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+9K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+9K241211CoLumboSmart Soft Healthcare20242—
+9K220497CoLumboSmart Soft Healthcare AD20226—
+9K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+9K200703JiveXVisus Health IT GmbH20202—
+10K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+10K250367CoLumboXSmart Soft Healthcare AD20250—
+10K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—