510(k) Report

Devices descending from K030420

112 later devices reach Lightspeed 5.0 Computed Tomography System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060052GE Lightspeed Xtra CT Scanner SystemGe Medical Systems, LLC2006133
+1K052855Starspeed Series CT Scanner SystemsGE Healthcare2005175
+1K052447Synerad Impact 60, Synerad Impact 72 and Analogic AMS1600Analogic Corp.20050—
+1K043381Infinia LightspeedGe Medical Systems F.I. Haifa20041—
+1K040372Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC2004865
+1K033502Lightspeed 6.0 CT Scanner SystemGe Medical Systems, LLC20031—
+2K151372Low Dose CT Lung Cancer Screening Option for Qualified GE SystemsGe Medical Systems, LLC20150—
+2K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801
+2K082761GE Lightspeed 7.2 CT Scanner SystemGe Medical Systems, LLC200873
+2K082816GE Brightspeed Delight CT Scanner SystemGe Medical Systems, LLC2008169
+2K082104GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 / Lightspeed…Ge Medical Systems, Inc.2008121
+2K061817Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC2006451
+2K052216Somatom DefinitionSiemens Medical Systems, Inc.200538—
+3K123596Optima CT520Ge Hangwei Medical Systems Co., Ltd.201315
+3K122471Somatom DefinitionSiemens Medical Systems, Inc.2012283
+3K110227Optima CT660Ge Medical Systems, LLC201165
+3K093581Discovery Model CT590 RT and Optima Model CT580 CT SystemsGe Medical Systems, LLC2011114
+3K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa200913Class I
+3K082220Somatom Flash DSSiemens Medical Solutions USA, Inc.200836—
+3K081105GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare2008355
+4K243605AuroraGe Medical Systems Israel, Functional Imaging20251—
+4K173816NM/CT 850, NM/CT 860GE Healthcare20180Class I
+4K171013Revolution ACTGe Hangwei Medical Systems Co., Ltd.20170—
+4K153402Discovery NM/CT 670 CZTGE Healthcare20166Class I
+4K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc.20152716
+4K133640ASIR-VGe Medical Systems, LLC20149—
+4K132410Discovery CT 590 RT, Optima CT 580, Optima CT 580 RT, Optima CT 580 WGe Medical Systems, LLC201402
+4K131576Optima CT660Ge Medical Systems, LLC201358
+4K120833Discovery CT750 HDGe Medical Systems, LLC2012281
+4K121072Somatom Definition FlashSiemens Medical Systems, Inc.2012315
+4K113342Somatom Definition FlashSiemens Medical Systems, Inc.2011321
+4K103424SafireSiemens Medical Solutions USA, Inc.20112—
+4K103489GE Veo Reconstruction OptionGeneral Electric Co.201110—
+4K111445Discovery NM 630GE Healthcare20112Class I
+4K090462Brilliance Dual Energy OptionPhilips Medical Systems (Cleveland), Inc.20093—
+5K251153AuroraGe Medical Systems Israel20250—
+5K210173StarGuideGE Healthcare20211—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K192686Revolution Maxima, Revolution AceGe Hangwei Medical Systems Co., Ltd.201945
+5K183202Deep Learning Image ReconstructionGe Medical Systems, LLC20198—
+5K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+5K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.2018204
+5K173023Symbia T16, Symbia Intevo 16 and Symbia Intevo BoldSiemens Medical Solutions USA, Inc.20170—
+5K163296SOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc.2017196
+5K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc.2016211
+5K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.2016244
+5K143416SOMATOM Definition Flash (VA48)Siemens Medical Solutions USA, Inc.2015255
+5K133646AdmireSiemens Medical Systems, Inc.20141—
+5K133589Somatom ForceSiemens Medical Solutions USA, Inc.2014299
+5K133705Revolution CTGe Medical Systems, LLC20142114
+5K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+5K121827Gsi Viewer with Vue OptionGE Medical Systems SCS20122—
+5K121019Optima NM/CT 640GE Healthcare20120Class I
+5K113350Brivo NM 615GE Healthcare20110Class I
+5K0937033DIShina Systems, Ltd.20102—
+6K241350Clarify DLGe Medical Systems Israel, Functional Imaging20250—
+6K223514Spectral Bone MarrowGe Medical Systems, LLC20230—
+6K213465CardioGrapheArineta, Ltd.20223—
+6K220961Deep Learning Image ReconstructionGe Healthcare Japan Corporation20220—
+6K213999Deep Learning Image ReconstructionGe Medical Systems, LLC20222—
+6K201745Deep Learning Image Reconstruction for Gemstone Spectral ImagingGe Medical Systems, LLC20200—
+6K203169Revolution AscendGe Healthcare Japan Corporation202031
+6K193073Deep ReconShanghai United Imaging Healthcare Co., Ltd.20200—
+6K193170Deep Learning Image ReconstructionGe Healthcare Japan Corporation20191—
+6K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+6K190578SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.20191913
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K180225GSI Viewer with GSI Fat OptionGE Medical Systems SCS20180—
+6K173632SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOSiemens Medical Solutions USA, Inc.20181818
+6K163297Scan&GOSiemens Medical Solutions USA, Inc.201719—
+6K163213Revolution CTGe Medical Systems, LLC20161516
+6K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+6K161066SpotLight CTArineta, Ltd.20164—
+6K153360AdmireSiemens Medi Cal Solutions, Inc.20160—
+6K1125303DI Including CscoreShina Systems, Ltd.20111—
+7K253686True Definition DLGe Healthcare Japan Corporation20260—
+7K230370SpotLight/SpotLight Duo (with DLIR option)Arineta, Ltd.20232—
+7K230421SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc.20233—
+7K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+7K230807Deep Learning Image ReconstructionGe Healthcare Japan Corporation20230—
+7K213938Revolution AscendGe Healthcare Japan Corporation202222
+7K211591NAEOTOM Alpha, Scan&GOSiemens Medical Solutions USA, Inc.20214—
+7K212067Deep Learning Image ReconstructionGe Healthcare Japan Corporation20210—
+7K192061SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan &…Siemens Medical Solutions USA, Inc.2019162
+7K191891SOMATOM X.citeSiemens Medical Solutions USA, Inc.201915—
+7K191777Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionGe Medical Systems, LLC2019518
+7K1134423DIShina Systems, Ltd.20120—
+8K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—
+8K241200SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd.20251—
+8K233698True Enhance DLGe Healthcare Japan Corporation20240—
+8K233657NAEOTOM AlphaSiemens Medical Solutions USA, Inc.20242—
+8K233749Revolution Ascend SlidingGe Hangwei Medical Systems Co., Ltd.20240—
+8K220814NAEOTOM Alpha, Scan&GO SoftwareSiemens Medical Solutions USA, Inc.202231
+8K213715Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex…Ge Medical Systems, LLC2021411
+8K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+8K200524SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim…Siemens Medical Solutions USA, Inc.2020147
+9K253560Enhanced Boundary for PCCTGe Medical Systems, LLC20260—
+9K253520Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC20260—
+9K250941Revolution VibeGe Medical Systems, LLC20250—
+9K250650SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd.20250—