HeartFocus (V.1.1.1)— 510(k) K242807

Substantially Equivalent

Deski

FDA 510(k) clearance K242807 for HeartFocus (V.1.1.1), Substantially Equivalent on 2025-04-04. Applicant: Deski. Device class: 2.

Clearance details

Applicant: Deski
Product code: Code QJU
Device class: Class 2
Regulation: 21 CFR 892.2100
Advisory panel: Radiology
Date received: 2024-09-17
Decision date: 2025-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bordeaux, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QJU

K260338 — ThinkSono Guidance2026-07-15
K260780 — HeartFocus2026-06-03
K251416 — UltraSight Guidance2025-12-17
K243065 — Cardiac Guidance2025-01-15
K223347 — UltraSight AI Guidance2023-07-24

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