510(k) Report

Devices descending from K223447

3 later devices reach OmniTom Elite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233767OmniTom EliteNeurologica Corporation20242—
+2K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—
+2K250928OmniTom Elite with PCDNeurologica Corporation20250—