510(k) Report

Devices descending from K945188

283 later devices reach Cemax Vipstation and/or Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+9K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+9K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+9K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+9K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+9K243069Lumys (V1)Intradys20250—
+9K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+9K233998TRAQinform IQAiq Global, Inc.20240—
+9K241302SonoSyncSamsung Medison Co., Ltd.20240—
+9K241440HealthCCSngNano-X AI, Ltd.20240—
+9K233457RUSHutom, Inc.20240—
+9K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+9K233080HealthFLDNano-X AI, Ltd.20240—
+9K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+9K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+9K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+9K230112CAC SoftwareImbio, Inc.20230—
+9K230223iCAC DeviceBunkerhill, Inc.20236—
+9K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+9K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+9K201948AcroDTI VisualizerAcroviz, Inc.20200—
+9K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+9K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+9K2001613MP Monochrome Digital Mammography LCD Monitor MS-S300Jvckenwood Corporation20200—
+9K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+9K180563syngo.plazaSiemens Healthcare GmbH20180—
+9K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+9K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+9K142750JiveXVisus Technology Transfer GmbH20156—
+9K13351121.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025)Jvckenwood Corporation20131—
+10K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+10K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+10K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+10K260166Bunkerhill Contrast CACBunkerHill Health20260—
+10K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+10K250662Bunkerhill MACBunkerHill Health20250—
+10K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+10K243229Bunkerhill AVCBunkerHill Health20253—
+10K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+10K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+10K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+10K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+10K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+10K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+10K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+10K2103452MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation20210—
+10K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+10K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+10K200132AshvinsMedicalcommunications GmbH202001
+10K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+10K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+10K162008JiveXVisus Technology Transfer GmbH20164—
+11K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+11K252571mdprostateMediaire GmbH20260—
+11K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+11K253690LungMapsSiemens Healthineers AG20260—
+11K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+11K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+11K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+11K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+11K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+11K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+11K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+11K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+11K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+11K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+11K181964JiveXVisus Health IT GmbH20183—
+12K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+12K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+12K241211CoLumboSmart Soft Healthcare20242—
+12K220497CoLumboSmart Soft Healthcare AD20226—
+12K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+12K200703JiveXVisus Health IT GmbH20202—
+13K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+13K250367CoLumboXSmart Soft Healthcare AD20250—
+13K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+13K240793MSKaiMskai20240—
+13K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+13K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+13K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+13K212321JiveX (Model Number / Release: 5.3)Visus Health IT GmbH20211—
+14K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+14K231041JiveX (Model Number / Release: 5.4)Visus Health IT GmbH20230—