510(k) Report

Devices descending from K944131

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964890Anatom 2000Analogic Corp.199737—
+2K051765Ceretom, Model NL3000Neurologica Corporation200527—
+2K982631Philips Tomoscan CSPhilips Medical Systems, Inc.199818—
+3K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+3K172539CereTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20170—
+3K171183OmniTomNeurologica Corporation201762
+3K102677Bodytom NL 4000Neurologica Corporation20119—
+3K090811Inspira HD, Model: NL1000Neurologica Corporation200910—
+3K061834Xcat; Xcat for NeuroXoran Technologies, Inc.20066—
+3K991278Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc.199917—
+4K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+4K202526OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics202051
+4K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20174—
+4K143435Planmed VerityPlanmed OY20152—
+4K142697NExCT 7Neurologica Corporation20140—
+4K131431Airo CT SystemMobius Imaging, LLC201321
+4K121418Planmed VerityPlanmed OY20132—
+4K014240ProntoHitachi Medical Systems America, Inc.200216—
+5K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company20260—
+5K213649BodyTom 64Neurologica Corporation20222—
+5K211711OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20224—
+5K180918Planmed VerityPlanmed OY20181—
+5K160723OnSight 3D Extremity SystemCarestream Health, Inc.20161—
+5K160126AIRO Computed Tomography (CT) X-ray SystemMobius Imaging201612
+5K040902Hitachi PrestoHitachi Medical Systems America, Inc.2004154
+6K252249Extremity CT Imaging SystemMars Bioimaging, Ltd.20260—
+6K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung20251—
+6K223447OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung20233—
+6K213278Planmed VerityPlanmed OY20220—
+6K180393AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC201805
+6K091103Guideshot Option for CXR4 and Eclos CT SystemsHitachi Medical Systems America, Inc.20091—
+6K071806Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc.2007121
+6K053148CXR16Hitachi Medical Systems America, Inc.20060—
+6K042428SCEPTREP3 Pet/CTHitachi Medical Systems America, Inc.200402
+7K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—
+7K233767OmniTom EliteNeurologica Corporation20242—
+7K113341Guideshot Option, Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.20120—
+8K250928OmniTom Elite with PCDNeurologica Corporation20250—