Clearance Summary
OmniTom Elite received FDA 510(k) clearance under submission number K211711, sponsored by Neurologica Corporation, A Subsidiary of Samsung Electronics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2022-02-25.
- Submission: K211711
- Applicant / Sponsor: Neurologica Corporation, A Subsidiary of Samsung Electronics
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2022-02-25
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.