510(k) Report

Devices descending from K051765

27 later devices reach Ceretom, Model NL3000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+1K172539CereTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20170—
+1K171183OmniTomNeurologica Corporation201762
+1K102677Bodytom NL 4000Neurologica Corporation20119—
+1K090811Inspira HD, Model: NL1000Neurologica Corporation200910—
+1K061834Xcat; Xcat for NeuroXoran Technologies, Inc.20066—
+2K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+2K202526OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics202051
+2K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20174—
+2K143435Planmed VerityPlanmed OY20152—
+2K142697NExCT 7Neurologica Corporation20140—
+2K131431Airo CT SystemMobius Imaging, LLC201321
+2K121418Planmed VerityPlanmed OY20132—
+3K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company20260—
+3K213649BodyTom 64Neurologica Corporation20222—
+3K211711OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20224—
+3K180918Planmed VerityPlanmed OY20181—
+3K160723OnSight 3D Extremity SystemCarestream Health, Inc.20161—
+3K160126AIRO Computed Tomography (CT) X-ray SystemMobius Imaging201612
+4K252249Extremity CT Imaging SystemMars Bioimaging, Ltd.20260—
+4K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung20251—
+4K223447OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung20233—
+4K213278Planmed VerityPlanmed OY20220—
+4K180393AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC201805
+5K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—
+5K233767OmniTom EliteNeurologica Corporation20242—
+6K250928OmniTom Elite with PCDNeurologica Corporation20250—