EchoGo Core (2.0)— 510(k) K213275

Substantially Equivalent

Ultromics Limited

FDA 510(k) clearance K213275 for EchoGo Core (2.0), Substantially Equivalent on 2021-12-20. Applicant: Ultromics Limited. Device class: 2.

Clearance details

Applicant: Ultromics Limited
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2021-09-30
Decision date: 2021-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, 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 Ultromics Limited

K240860 — EchoGo Amyloidosis (1.0)2024-11-15
K240013 — EchoGo Heart Failure (2.0)2024-09-23
K222463 — EchoGo Heart Failure2022-11-23

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