EchoSolv AS— 510(k) K241245

Substantially Equivalent

Echo IQ, Ltd.

FDA 510(k) clearance K241245 for EchoSolv AS, Substantially Equivalent on 2024-10-04. Applicant: Echo IQ, Ltd.. Device class: 2.

Clearance details

Applicant: Echo IQ, Ltd.
Product code: Code POK
Device class: Class 2
Regulation: 21 CFR 892.2060
Advisory panel: Radiology
Date received: 2024-05-03
Decision date: 2024-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code POK

K253884 — Koios DS (3.8)2026-07-02
K261519 — Sonio Suspect2026-06-04
K254161 — Automated Aortic Stenosis Software (AutoAS)2026-03-27
K251769 — RevealAI-Lung2026-01-30
K252294 — Fetal EchoScan (v1.2)2025-12-08

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