510(k) Report

Devices descending from K202526

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211711OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20224—
+2K223447OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung20233—
+3K233767OmniTom EliteNeurologica Corporation20242—
+4K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—
+4K250928OmniTom Elite with PCDNeurologica Corporation20250—