510(k) Report

Devices descending from K081022

63 later devices reach Somatom Definition, Model as/as+ through their predicates, nearest generation first.

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