510(k) Report

Devices descending from K063189

67 later devices reach TSX-301A, Aquilion One CT System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081022Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc.2008633
+1K072606Aquilion One TSX-301A/2 Computed Tomography SystemToshiba America Medical Systems, In.C200724
+2K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc.20152716
+2K130224ICTImris, Inc.20130—
+2K103127Somatom Definition asSiemens Medical Solutions USA, Inc.2011536
+2K083282Model TSX-301B Aquilion CT SystemToshiba America Medical Systems, In.C200818
+2K082220Somatom Flash DSSiemens Medical Solutions USA, Inc.200836—
+3K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.2018204
+3K172058CT6485, CT12885Analogic Corporation20182—
+3K173023Symbia T16, Symbia Intevo 16 and Symbia Intevo BoldSiemens Medical Solutions USA, Inc.20170—
+3K163296SOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc.2017196
+3K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc.2016211
+3K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.2016244
+3K130901Somatom Definition as OpenSiemens Medical Systems, Inc.201449—
+3K120546Aquilion PremiumToshiba Medical Systems Corporation, Japan201202
+3K121072Somatom Definition FlashSiemens Medical Systems, Inc.2012315
+3K113342Somatom Definition FlashSiemens Medical Systems, Inc.2011321
+3K103424SafireSiemens Medical Solutions USA, Inc.20112—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K190578SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.20191913
+4K182147CTXX85Analogic Corporation20181—
+4K173632SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOSiemens Medical Solutions USA, Inc.20181818
+4K163297Scan&GOSiemens Medical Solutions USA, Inc.201719—
+4K143416SOMATOM Definition Flash (VA48)Siemens Medical Solutions USA, Inc.2015255
+4K143400SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc.2015325
+4K143401SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc.2015353
+4K143409SOMATOM Definition AS Open (VA48)Siemens Medical Solutions USA, Inc.2015212
+4K142584iMARSiemens Medical Solutions USA, Inc.20150—
+4K133646AdmireSiemens Medical Systems, Inc.20141—
+4K133589Somatom ForceSiemens Medical Solutions USA, Inc.2014299
+5K230421SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc.20233—
+5K211591NAEOTOM Alpha, Scan&GOSiemens Medical Solutions USA, Inc.20214—
+5K201231CTxx85 CT ScannerAnalogic Corporation20210—
+5K192061SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan &…Siemens Medical Solutions USA, Inc.2019162
+5K191891SOMATOM X.citeSiemens Medical Solutions USA, Inc.201915—
+5K170273Z-DOSE29Zetta Medical Technologies, LLC20170—
+5K153360AdmireSiemens Medi Cal Solutions, Inc.20160—
+5K153331SafeCT-29Medic Vision Imaging Solutions20161—
+5K151765SOMATOM PerspectiveSiemens Medical Solutions USA, Inc.201602
+5K151749somatom Scope (with syngo CT VC30-easyIQ version), SOMATOM Scope Power (with syngo CT…Siemens Medical Solutions USA, Inc.201602
+5K151752SOMATOM Emotion 6/16Siemens Medical Solutions USA, Inc.20152—
+5K152036SOMATOM Definition Edge, SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc.2015284
+6K233657NAEOTOM AlphaSiemens Medical Solutions USA, Inc.20242—
+6K220814NAEOTOM Alpha, Scan&GO SoftwareSiemens Medical Solutions USA, Inc.202231
+6K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+6K200524SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim…Siemens Medical Solutions USA, Inc.2020147
+6K173076CURA 16; ScintCare CT16Fmi Medical Systems, Inc.20181—
+6K173607SOMATOM Edge PlusSiemens Medical Solutions USA, Inc.2018203
+6K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+7K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc.20251—
+7K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+7K211373SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X.…Siemens Medical Solutions USA, Inc.2021123
+7K192590CURA 778Fmi Medical Systems, Inc.20200—
+7K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+8K251061NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc.202503
+8K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM…Siemens Medical Solutions USA, Inc.202451
+8K232206SOMATOM Pro.PulseSiemens Medical Solutions USA, Inc.20232—
+8K230162uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202324
+8K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+9K253574SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc.20260—
+9K250822SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM…Siemens Medical Solutions USA, Inc.20251—
+9K241079uCT 780Shanghai United Imaging Healthcare Co., Ltd.202512
+9K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+10K253173uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202601
+10K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+11K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+12K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—