510(k) Report

Devices descending from K990491

33 later devices reach Angio-CT Miyabi through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032475Somaton Computed Tomography X-Ray Systems Sliding Gantry OptionSiemens Medical Solutions USA, Inc.20031—
+1K991600Somatom Plus 4 with Sliding Gantry OptionSiemens Corp.199932—
+2K160611P-ArtisP-Cure, Ltd.20161—
+2K130224ICTImris, Inc.20130—
+2K051765Ceretom, Model NL3000Neurologica Corporation200527—
+3K250970MarieLeo Cancer Care20250—
+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—
+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—
+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
+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
+7K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—
+7K233767OmniTom EliteNeurologica Corporation20242—
+8K250928OmniTom Elite with PCDNeurologica Corporation20250—