HeartFocus— 510(k) K260780

Substantially Equivalent

Deski

FDA 510(k) clearance K260780 for HeartFocus, Substantially Equivalent on 2026-06-03. 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: 2026-03-10
Decision date: 2026-06-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Bordeaux, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QJU

K260338 — ThinkSono Guidance2026-07-15
K251416 — UltraSight Guidance2025-12-17
K242807 — HeartFocus (V.1.1.1)2025-04-04
K243065 — Cardiac Guidance2025-01-15
K223347 — UltraSight AI Guidance2023-07-24

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