Us2.v1— 510(k) K210791

Substantially Equivalent

Eko.Ai Pte Ltd. D/B/A Us2.Ai

FDA 510(k) clearance K210791 for Us2.v1, Substantially Equivalent on 2021-07-27. Applicant: Eko.Ai Pte Ltd. D/B/A Us2.Ai. Device class: 2.

Clearance details

Applicant: Eko.Ai Pte Ltd. D/B/A Us2.Ai
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2021-03-16
Decision date: 2021-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

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K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Eko.Ai Pte Ltd. D/B/A Us2.Ai

K250151 — Us2.ca2025-06-20
K233676 — Us2.v22024-04-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.