EchoConfidence (USA)— 510(k) K250670

Substantially Equivalent

Mycardium AI Limited

FDA 510(k) clearance K250670 for EchoConfidence (USA), Substantially Equivalent on 2025-06-30. Applicant: Mycardium AI Limited. Device class: 2.

Clearance details

Applicant: Mycardium AI Limited
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-03-05
Decision date: 2025-06-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Liverpool, GB

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 Mycardium AI Limited

K242062 — 1CMR Pro2024-11-15

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