510(k) Report

Devices descending from K213649

2 later devices reach BodyTom 64 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung20251—
+2K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—