Clearance Summary
Us2.v2 received FDA 510(k) clearance under submission number K233676, sponsored by Eko.Ai Pte Ltd. D/B/A Us2.Ai. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-04-01.
- Submission: K233676
- Applicant / Sponsor: Eko.Ai Pte Ltd. D/B/A Us2.Ai
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2024-04-01
Classification & Regulation
This clearance is catalogued under FDA product code QIH and 21 CFR 892.2050, within the Radiology review panel as a Class II device.