510(k) Report

Devices descending from K000300

49 later devices reach Lightspeed 2.0CT Scanner System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052855Starspeed Series CT Scanner SystemsGE Healthcare2005175
+1K051765Ceretom, Model NL3000Neurologica Corporation200527—
+1K023332Lightspeed Ultra Computed Tomography System with Wide-ViewGE Medical Systems20021—
+1K012836Modification to: Lightspeed Plus Mobile CT SystemGE Medical Systems20010—
+2K203617MaxFOV 2Ge Medical Systems, LLC20210—
+2K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+2K172539CereTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20170—
+2K171183OmniTomNeurologica Corporation201762
+2K102677Bodytom NL 4000Neurologica Corporation20119—
+2K090811Inspira HD, Model: NL1000Neurologica Corporation200910—
+2K082816GE Brightspeed Delight CT Scanner SystemGe Medical Systems, LLC2008169
+2K061834Xcat; Xcat for NeuroXoran Technologies, Inc.20066—
+3K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+3K202526OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics202051
+3K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20174—
+3K143435Planmed VerityPlanmed OY20152—
+3K142697NExCT 7Neurologica Corporation20140—
+3K131431Airo CT SystemMobius Imaging, LLC201321
+3K123596Optima CT520Ge Hangwei Medical Systems Co., Ltd.201315
+3K121418Planmed VerityPlanmed OY20132—
+3K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa200913Class I
+4K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company20260—
+4K243605AuroraGe Medical Systems Israel, Functional Imaging20251—
+4K213649BodyTom 64Neurologica Corporation20222—
+4K211711OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20224—
+4K180918Planmed VerityPlanmed OY20181—
+4K173816NM/CT 850, NM/CT 860GE Healthcare20180Class I
+4K171013Revolution ACTGe Hangwei Medical Systems Co., Ltd.20170—
+4K160723OnSight 3D Extremity SystemCarestream Health, Inc.20161—
+4K160126AIRO Computed Tomography (CT) X-ray SystemMobius Imaging201612
+4K153402Discovery NM/CT 670 CZTGE Healthcare20166Class I
+4K111445Discovery NM 630GE Healthcare20112Class I
+5K252249Extremity CT Imaging SystemMars Bioimaging, Ltd.20260—
+5K251153AuroraGe Medical Systems Israel20250—
+5K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung20251—
+5K223447OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung20233—
+5K213278Planmed VerityPlanmed OY20220—
+5K210173StarGuideGE Healthcare20211—
+5K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+5K180393AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC201805
+5K121019Optima NM/CT 640GE Healthcare20120Class I
+5K113350Brivo NM 615GE Healthcare20110Class I
+6K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—
+6K241350Clarify DLGe Medical Systems Israel, Functional Imaging20250—
+6K233767OmniTom EliteNeurologica Corporation20242—
+6K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+7K250928OmniTom Elite with PCDNeurologica Corporation20250—
+7K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+8K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—