Clearance Summary
BodyTom 64 (NL4100); OmniTom Elite (NL5000) received FDA 510(k) clearance under submission number K261125, sponsored by Samsung HME America, Inc., dba NeuroLogica Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-09-22.
- Submission: K261125
- Applicant / Sponsor: Samsung HME America, Inc., dba NeuroLogica Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2026-09-22
Classification & Regulation
This clearance is catalogued under FDA product code JAK and 21 CFR 892.1750, within the Radiology review panel as a Class II device.