510(k) Report

Devices descending from K102677

9 later devices reach Bodytom NL 4000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20174—
+1K142697NExCT 7Neurologica Corporation20140—
+1K131431Airo CT SystemMobius Imaging, LLC201321
+2K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company20260—
+2K213649BodyTom 64Neurologica Corporation20222—
+2K160126AIRO Computed Tomography (CT) X-ray SystemMobius Imaging201612
+3K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung20251—
+3K180393AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC201805
+4K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—