510(k) Report

Devices descending from K040372

86 later devices reach Lightspeed 7.0 CT Scanner System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151372Low Dose CT Lung Cancer Screening Option for Qualified GE SystemsGe Medical Systems, LLC20150—
+1K082761GE Lightspeed 7.2 CT Scanner SystemGe Medical Systems, LLC200873
+1K061817Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC2006451
+1K052216Somatom DefinitionSiemens Medical Systems, Inc.200538—
+2K122471Somatom DefinitionSiemens Medical Systems, Inc.2012283
+2K110227Optima CT660Ge Medical Systems, LLC201165
+2K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801
+2K082220Somatom Flash DSSiemens Medical Solutions USA, Inc.200836—
+2K081105GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare2008355
+3K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc.20152716
+3K131576Optima CT660Ge Medical Systems, LLC201358
+3K120833Discovery CT750 HDGe Medical Systems, LLC2012281
+3K121072Somatom Definition FlashSiemens Medical Systems, Inc.2012315
+3K113342Somatom Definition FlashSiemens Medical Systems, Inc.2011321
+3K103424SafireSiemens Medical Solutions USA, Inc.20112—
+3K103489GE Veo Reconstruction OptionGeneral Electric Co.201110—
+3K090462Brilliance Dual Energy OptionPhilips Medical Systems (Cleveland), Inc.20093—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K192686Revolution Maxima, Revolution AceGe Hangwei Medical Systems Co., Ltd.201945
+4K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.2018204
+4K173023Symbia T16, Symbia Intevo 16 and Symbia Intevo BoldSiemens Medical Solutions USA, Inc.20170—
+4K163296SOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc.2017196
+4K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc.2016211
+4K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.2016244
+4K143416SOMATOM Definition Flash (VA48)Siemens Medical Solutions USA, Inc.2015255
+4K133646AdmireSiemens Medical Systems, Inc.20141—
+4K133589Somatom ForceSiemens Medical Solutions USA, Inc.2014299
+4K133705Revolution CTGe Medical Systems, LLC20142114
+4K133640ASIR-VGe Medical Systems, LLC20149—
+4K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+4K121827Gsi Viewer with Vue OptionGE Medical Systems SCS20122—
+4K0937033DIShina Systems, Ltd.20102—
+5K223514Spectral Bone MarrowGe Medical Systems, LLC20230—
+5K213465CardioGrapheArineta, Ltd.20223—
+5K203169Revolution AscendGe Healthcare Japan Corporation202031
+5K190578SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.20191913
+5K183202Deep Learning Image ReconstructionGe Medical Systems, LLC20198—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K180225GSI Viewer with GSI Fat OptionGE Medical Systems SCS20180—
+5K173632SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOSiemens Medical Solutions USA, Inc.20181818
+5K163297Scan&GOSiemens Medical Solutions USA, Inc.201719—
+5K163213Revolution CTGe Medical Systems, LLC20161516
+5K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+5K161066SpotLight CTArineta, Ltd.20164—
+5K153360AdmireSiemens Medi Cal Solutions, Inc.20160—
+5K1125303DI Including CscoreShina Systems, Ltd.20111—
+6K230370SpotLight/SpotLight Duo (with DLIR option)Arineta, Ltd.20232—
+6K230421SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc.20233—
+6K220961Deep Learning Image ReconstructionGe Healthcare Japan Corporation20220—
+6K213999Deep Learning Image ReconstructionGe Medical Systems, LLC20222—
+6K213938Revolution AscendGe Healthcare Japan Corporation202222
+6K211591NAEOTOM Alpha, Scan&GOSiemens Medical Solutions USA, Inc.20214—
+6K201745Deep Learning Image Reconstruction for Gemstone Spectral ImagingGe Medical Systems, LLC20200—
+6K193073Deep ReconShanghai United Imaging Healthcare Co., Ltd.20200—
+6K193170Deep Learning Image ReconstructionGe Healthcare Japan Corporation20191—
+6K192061SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan &…Siemens Medical Solutions USA, Inc.2019162
+6K191891SOMATOM X.citeSiemens Medical Solutions USA, Inc.201915—
+6K191777Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionGe Medical Systems, LLC2019518
+6K1134423DIShina Systems, Ltd.20120—
+7K253686True Definition DLGe Healthcare Japan Corporation20260—
+7K241200SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd.20251—
+7K233698True Enhance DLGe Healthcare Japan Corporation20240—
+7K233657NAEOTOM AlphaSiemens Medical Solutions USA, Inc.20242—
+7K233749Revolution Ascend SlidingGe Hangwei Medical Systems Co., Ltd.20240—
+7K230807Deep Learning Image ReconstructionGe Healthcare Japan Corporation20230—
+7K220814NAEOTOM Alpha, Scan&GO SoftwareSiemens Medical Solutions USA, Inc.202231
+7K213715Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex…Ge Medical Systems, LLC2021411
+7K212067Deep Learning Image ReconstructionGe Healthcare Japan Corporation20210—
+7K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+7K200524SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim…Siemens Medical Solutions USA, Inc.2020147
+8K253560Enhanced Boundary for PCCTGe Medical Systems, LLC20260—
+8K253520Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC20260—
+8K250941Revolution VibeGe Medical Systems, LLC20250—
+8K250650SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd.20250—
+8K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc.20251—
+8K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+8K233750ECG-less CardiacGe Medical Systems, LLC20240—
+8K211373SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X.…Siemens Medical Solutions USA, Inc.2021123
+9K251061NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc.202503
+9K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM…Siemens Medical Solutions USA, Inc.202451
+9K232206SOMATOM Pro.PulseSiemens Medical Solutions USA, Inc.20232—
+9K230162uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202324
+10K253574SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc.20260—
+10K250822SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM…Siemens Medical Solutions USA, Inc.20251—
+10K241079uCT 780Shanghai United Imaging Healthcare Co., Ltd.202512
+11K253173uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202601