meddevicedb.com FDA Device Reference

Us2.v1

K210791 Class II Traditional
Decision Date
2021-07-27
Sponsor / Applicant
Eko.Ai Pte Ltd. D/B/A Us2.Ai

Technical Specification

510(k) Submission ID K210791
Product Code QIH
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2050
Decision Date 2021-07-27
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Us2.v1 received FDA 510(k) clearance under submission number K210791, 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 2021-07-27.

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.