Cleared Special

K260780 - HeartFocus (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260780 · Deski · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
85d
Days
Class 2
Risk

K260780 is an FDA 510(k) clearance for the HeartFocus. Classified as Image Acquisition And/or Optimization Guided By Artificial Intelligence (product code QJU), Class II - Special Controls.

Submitted by Deski (Bordeaux, FR). The FDA issued a Cleared decision on June 3, 2026 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2100 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Deski devices

Submission Details

510(k) Number K260780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2026
Decision Date June 03, 2026
Days to Decision 85 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QJU Image Acquisition And/or Optimization Guided By Artificial Intelligence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2100
Definition A Radiological Acquisition And/or Optimization Guidance System Is A Device That Is Intended To Aid In The Acquisition And/or Optimization Of Images And/or Diagnostic Signals. The Device Interfaces With The Acquisition System, Analyzes Its Output, And Provides Guidance And/or Feedback To The Operator For Improving Image And/or Signal Quality.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - QJU Image Acquisition And/or Optimization Guided By Artificial Intelligence

All 7
Devices cleared under the same product code (QJU) and FDA review panel - the closest regulatory comparables to K260780.
UltraSight Guidance
K251416 · Ultrasight , Ltd. · Dec 2025
HeartFocus (V.1.1.1)
K242807 · Deski · Apr 2025
Cardiac Guidance
K243065 · Caption Health, Inc. · Jan 2025
UltraSight AI Guidance
K223347 · Ultrasight, Inc. · Jul 2023
Caption Guidance
K201992 · Caption Health · Sep 2020
Caption Guidance
K200755 · Caption Health · Apr 2020