510(k) Report

Devices descending from K982349

143 later devices reach Somatom Plus 4WITH Volume Zoom CT Scanners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc.20152716
+1K013522Somatom P30 CT SystemsSiemens Medical Systems, Inc.20011429
+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—
+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
+2K140232Syngo CT 2014A (Somaris/5 VB42) for Somatom Emotion & Sensation Family CTSiemens Medical Solutions USA, Inc.20140—
+2K052216Somatom DefinitionSiemens Medical Systems, Inc.200538—
+2K040665Somatom Sensation 64 and Sensation CardiacSiemens Medical Solutions USA, Inc.20041365
+2K040577Somatom Project P30LSiemens Medical Systems, Inc.200452
+2K032536Somatom Extended Field of View Software OptionSiemens Medical Solutions USA, Inc.20031—
+3K190578SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.20191913
+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—
+3K121792Neuviz 64 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.201215
+3K122471Somatom DefinitionSiemens Medical Systems, Inc.2012283
+3K082220Somatom Flash DSSiemens Medical Solutions USA, Inc.200836—
+3K081022Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc.2008633
+3K063241CSTC-002A, Extended Field of View Software OptionToshiba America Medical Systems, In.C20060—
+3K060631Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc.2006643
+3K043086Somatom Respiratory GatingSiemens Medical Solutions USA, Inc.20040—
+3K043087Somatom Care Contrast CTSiemens Medical Solutions USA, Inc.20042—
+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—
+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—
+4K173547ImagenUniversalCardiovascular Imaging Technologies20180—
+4K133373ClearviewNeusoft Medical Systems Co., Ltd.20140—
+4K130224ICTImris, Inc.20130—
+4K121072Somatom Definition FlashSiemens Medical Systems, Inc.2012315
+4K113342Somatom Definition FlashSiemens Medical Systems, Inc.2011321
+4K103424SafireSiemens Medical Solutions USA, Inc.20112—
+4K103127Somatom Definition asSiemens Medical Solutions USA, Inc.2011536
+4K083852Biograph 16 True Point SystemsSiemens Medical Solutions USA, Inc.20090—
+4K082960GE Xtreme Injector OptionGe Medical Systems, LLC20080—
+4K081453Biograph HD FamilySiemens Medical Solutions USA, Inc.200862—
+4K071068Biograph 6 Truepoint, Model Biograph 6 - P/N 10238197Siemens Medical Solutions USA, Inc.20070—
+4K061976Ckis-004A Injector Synchronization OptionToshiba America Medical Systems, In.C20061—
+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—
+5K200315Ziostation2Ziosoft, Inc.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
+5K172058CT6485, CT12885Analogic Corporation20182—
+5K143416SOMATOM Definition Flash (VA48)Siemens Medical Solutions USA, Inc.2015255
+5K133646AdmireSiemens Medical Systems, Inc.20141—
+5K133589Somatom ForceSiemens Medical Solutions USA, Inc.2014299
+5K130901Somatom Definition as OpenSiemens Medical Systems, Inc.201449—
+5K103429Biograph MMRSiemens Medical Solutions USA, Inc.2011211
+5K101550Biograph MCT FamilySiemens Medical Solutions USA, Inc.201038—
+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
+6K182147CTXX85Analogic Corporation20181—
+6K153360AdmireSiemens Medi Cal Solutions, Inc.20160—
+6K143400SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc.2015325
+6K143401SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc.2015353
+6K143409SOMATOM Definition AS Open (VA48)Siemens Medical Solutions USA, Inc.2015212
+6K142584iMARSiemens Medical Solutions USA, Inc.20150—
+6K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+6K113448Biograph MCT FamilySiemens Medical Solutions USA, Inc.201137—
+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
+7K201231CTxx85 CT ScannerAnalogic Corporation20210—
+7K170273Z-DOSE29Zetta Medical Technologies, LLC20170—
+7K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+7K153331SafeCT-29Medic Vision Imaging Solutions20161—
+7K151765SOMATOM PerspectiveSiemens Medical Solutions USA, Inc.201602
+7K151749somatom Scope (with syngo CT VC30-easyIQ version), SOMATOM Scope Power (with syngo CT…Siemens Medical Solutions USA, Inc.201602
+7K151752SOMATOM Emotion 6/16Siemens Medical Solutions USA, Inc.20152—
+7K152036SOMATOM Definition Edge, SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc.2015284
+7K142098Signa Pet/MRGe Medical Systems, LLC201466
+7K123737Biograph MCT FamilySiemens Medical Solutions USA, Inc.20133617
+8K253963Cubresa BrainPETCubresa, Inc.20260—
+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
+8K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+8K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+8K173076CURA 16; ScintCare CT16Fmi Medical Systems, Inc.20181—
+8K173607SOMATOM Edge PlusSiemens Medical Solutions USA, Inc.2018203
+8K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+8K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+8K163619Signa Pet/MRGe Medical Systems, LLC201717
+8K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+8K151486Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc.20153411
+8K141971Biograph True Pet/CT Family SoftwareSiemens Medical Solutions USA, Inc.2014037
+9K253173uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202601
+9K253023BIOGRAPH OneSiemens Healthineers AG20260—
+9K213709Signa Pet/MRGe Medical Systems, LLC202203
+9K192590CURA 778Fmi Medical Systems, Inc.20200—
+9K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+9K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+9K172143uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018162
+9K173578Biograph mCT Family of PET/CT SystemsSiemens Medical Solutions USA, Inc.201792
+9K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+9K152880Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201651