510(k) · Cleared
ClearedHeartFocus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deski · QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Cleared on Jun 3, 2026 as substantially equivalent to K242807 (Deski, 2025) after an 85-day review. Its family tree reaches back 2 generations to 2020.
- Decided
- Jun 3, 2026
- Review
- 85 days
- Class
- Class II
- Product code
- QJU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN190040 (2020). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QJU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QJU device
- #1 K242807 HeartFocus (V.1.1.1)score 12.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K242807 | HeartFocus (V.1.1.1)Summary page 5…892.2100 Product Code(s) QJU | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K242807 HeartFocus QJU Device Description Summary 21 CFR 807.92(a)(4) DEVICE DESCRIPTION SUMMARY The HeartFocus software is a radiologi… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All QJU devicesQJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QJU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QJU
199in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJU
No recall names QJU since 2007.
Adverse event reports per year · QJU
No MAUDE report names QJU since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 3 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 199 | 0 | 0 |
| 2026 | 3 | 163 | 0 | — |
What is it indicated for?
The HeartFocus software is intended to assist and guide medical professionals in the acquisition of cardiac ultrasound images. HeartFocus software is an accessory to compatible general-purpose diagnostic ultrasound systems. Heartfocus guides the acquisition of two-dimensional transthoracic echocardiography (2D-TTE). Specifically, in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve…
Read the full statement (107 words)
The HeartFocus software is intended to assist and guide medical professionals in the acquisition of cardiac ultrasound images. HeartFocus software is an accessory to compatible general-purpose diagnostic ultrasound systems. Heartfocus guides the acquisition of two-dimensional transthoracic echocardiography (2D-TTE). Specifically, in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (A4C), Apical 5-Chamber (A5C), Apical 2-Chamber (A2C), Apical 3-Chamber (A3C), Subcostal 4-Chamber (SC-4C), and Subcostal Inferior Vena Cava (SC-IVC).
HeartFocus software is indicated for use in adult patients who require a cardiac ultrasound exam.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260780: HeartFocus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260780
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026