Clearance Summary
BodyTom 64 received FDA 510(k) clearance under submission number K242811, sponsored by Neurologica Corporation, A Subsidiary of Samsung. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-03-14.
- Submission: K242811
- Applicant / Sponsor: Neurologica Corporation, A Subsidiary of Samsung
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2025-03-14
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.