510(k) Report

Devices descending from K120579

122 later devices reach Somatom Definition Edge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172058CT6485, CT12885Analogic Corporation20182—
+1K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc.20152716
+1K143400SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc.2015325
+1K143401SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc.2015353
+1K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+1K123920Syngo.ViaSiemens AG Medical Solutions201363—
+2K223261Open RibCanon Medical Informatics, Inc.20230—
+2K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+2K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+2K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+2K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+2K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+2K182147CTXX85Analogic Corporation20181—
+2K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+2K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.2018204
+2K173023Symbia T16, Symbia Intevo 16 and Symbia Intevo BoldSiemens Medical Solutions USA, Inc.20170—
+2K170273Z-DOSE29Zetta Medical Technologies, LLC20170—
+2K163296SOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc.2017196
+2K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc.2016211
+2K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.2016244
+2K153331SafeCT-29Medic Vision Imaging Solutions20161—
+2K151765SOMATOM PerspectiveSiemens Medical Solutions USA, Inc.201602
+2K151749somatom Scope (with syngo CT VC30-easyIQ version), SOMATOM Scope Power (with syngo CT…Siemens Medical Solutions USA, Inc.201602
+2K151752SOMATOM Emotion 6/16Siemens Medical Solutions USA, Inc.20152—
+2K152036SOMATOM Definition Edge, SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc.2015284
+2K150843syngo®.via (version VB10A)Siemens AG201546—
+2K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+3K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+3K223424Spine Auto ViewsGE Medical Systems SCS20230—
+3K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+3K213944HealthOSTNanoxai, Ltd.20221—
+3K201231CTxx85 CT ScannerAnalogic Corporation20210—
+3K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+3K190578SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.20191913
+3K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+3K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+3K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+3K173076CURA 16; ScintCare CT16Fmi Medical Systems, Inc.20181—
+3K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+3K173632SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOSiemens Medical Solutions USA, Inc.20181818
+3K173607SOMATOM Edge PlusSiemens Medical Solutions USA, Inc.2018203
+3K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+3K163297Scan&GOSiemens Medical Solutions USA, Inc.201719—
+3K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+3K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+3K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+4K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+4K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+4K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+4K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+4K233080HealthFLDNano-X AI, Ltd.20240—
+4K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+4K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+4K230421SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc.20233—
+4K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+4K211591NAEOTOM Alpha, Scan&GOSiemens Medical Solutions USA, Inc.20214—
+4K201948AcroDTI VisualizerAcroviz, Inc.20200—
+4K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+4K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+4K192590CURA 778Fmi Medical Systems, Inc.20200—
+4K192061SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan &…Siemens Medical Solutions USA, Inc.2019162
+4K191891SOMATOM X.citeSiemens Medical Solutions USA, Inc.201915—
+4K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+4K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+4K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+4K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+5K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+5K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+5K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+5K233657NAEOTOM AlphaSiemens Medical Solutions USA, Inc.20242—
+5K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+5K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+5K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+5K220814NAEOTOM Alpha, Scan&GO SoftwareSiemens Medical Solutions USA, Inc.202231
+5K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+5K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+5K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+5K200899Quantib AI NodeQuantib B.V.20200—
+5K200524SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim…Siemens Medical Solutions USA, Inc.2020147
+5K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+5K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+5K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+6K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+6K252571mdprostateMediaire GmbH20260—
+6K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+6K253690LungMapsSiemens Healthineers AG20260—
+6K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+6K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+6K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+6K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc.20251—
+6K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+6K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+6K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+6K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+6K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+6K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+6K211373SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X.…Siemens Medical Solutions USA, Inc.2021123
+6K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+7K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+7K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—