510(k) Report

Devices descending from K953616

230 later devices reach Preview Surgery Planning Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K223261Open RibCanon Medical Informatics, Inc.20230—
+8K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+8K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+8K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+8K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+8K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+8K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+8K183037Monaco RTP SystemElekta, Inc.201856
+8K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+8K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+8K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+8K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+8K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+8K150843syngo®.via (version VB10A)Siemens AG201546—
+8K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+8K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+8K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+9K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+9K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+9K223424Spine Auto ViewsGE Medical Systems SCS20230—
+9K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+9K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K213944HealthOSTNanoxai, Ltd.20221—
+9K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+9K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+9K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+9K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+9K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+9K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+9K190178Monaco RTP SystemElekta, Inc.201945
+9K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+9K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+9K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+9K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+9K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+9K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+9K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+9K142647mint LesionMint Medical GmbH201523
+10K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+10K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+10K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+10K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+10K241440HealthCCSngNano-X AI, Ltd.20240—
+10K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+10K233080HealthFLDNano-X AI, Ltd.20240—
+10K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+10K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+10K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+10K230112CAC SoftwareImbio, Inc.20230—
+10K230223iCAC DeviceBunkerhill, Inc.20236—
+10K220929ExcelsiorMerit Cro, Inc.20220—
+10K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+10K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+10K202789Monaco Rtp SystemElekta Solutions AB20213—
+10K202229AI MetricsAi Metrics, LLC20200—
+10K201948AcroDTI VisualizerAcroviz, Inc.20200—
+10K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+10K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+10K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+10K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+10K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+10K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+10K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+11K260166Bunkerhill Contrast CACBunkerHill Health20260—
+11K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+11K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+11K250662Bunkerhill MACBunkerHill Health20250—
+11K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+11K243229Bunkerhill AVCBunkerHill Health20253—
+11K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+11K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+11K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+11K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+11K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+11K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+11K213787Monaco RTP SystemElekta Solutions AB20222—
+11K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+11K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+11K200899Quantib AI NodeQuantib B.V.20200—
+11K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+11K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+11K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+12K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+12K252571mdprostateMediaire GmbH20260—
+12K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+12K253690LungMapsSiemens Healthineers AG20260—
+12K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+12K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+12K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+12K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+12K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+12K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+12K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+12K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—