Us2.v2— 510(k) K233676

Substantially Equivalent

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

FDA 510(k) clearance K233676 for Us2.v2, Substantially Equivalent on 2024-04-01. 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: 2023-11-16
Decision date: 2024-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
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
K210791 — Us2.v12021-07-27

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