510(k) Report

Devices descending from K964890

37 later devices reach Anatom 2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051765Ceretom, Model NL3000Neurologica Corporation200527—
+1K982631Philips Tomoscan CSPhilips Medical Systems, Inc.199818—
+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—
+2K061834Xcat; Xcat for NeuroXoran Technologies, Inc.20066—
+2K991278Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc.199917—
+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
+3K121418Planmed VerityPlanmed OY20132—
+3K014240ProntoHitachi Medical Systems America, Inc.200216—
+4K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company20260—
+4K213649BodyTom 64Neurologica Corporation20222—
+4K211711OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20224—
+4K180918Planmed VerityPlanmed OY20181—
+4K160723OnSight 3D Extremity SystemCarestream Health, Inc.20161—
+4K160126AIRO Computed Tomography (CT) X-ray SystemMobius Imaging201612
+4K040902Hitachi PrestoHitachi Medical Systems America, Inc.2004154
+5K252249Extremity CT Imaging SystemMars Bioimaging, Ltd.20260—
+5K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung20251—
+5K223447OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung20233—
+5K213278Planmed VerityPlanmed OY20220—
+5K180393AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC201805
+5K091103Guideshot Option for CXR4 and Eclos CT SystemsHitachi Medical Systems America, Inc.20091—
+5K071806Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc.2007121
+5K053148CXR16Hitachi Medical Systems America, Inc.20060—
+5K042428SCEPTREP3 Pet/CTHitachi Medical Systems America, Inc.200402
+6K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—
+6K233767OmniTom EliteNeurologica Corporation20242—
+6K113341Guideshot Option, Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.20120—
+7K250928OmniTom Elite with PCDNeurologica Corporation20250—