Guides medical professionals acquiring ten standard 2D transthoracic echocardiographic views in adults requiring a cardiac ultrasound examination; acquired images require qualified clinical interpretation.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
Guides medical professionals acquiring ten standard 2D transthoracic echocardiographic views in adults requiring a cardiac ultrasound examination; acquired images require qualified clinical interpretation.
FDA source Exact FDA submission Checked 2026-09-05
Medical professionals trained in ultrasound basics and HeartFocus using DESKi training or approved materials delivered by a trained medical professional.
FDA source Exact FDA submission Checked 2026-09-05
Live ultrasound images for PLAX, PSAX-AV, PSAX-MV, PSAX-PM, A4C, A5C, A2C, A3C, SC-4C and SC-IVC views; the submission describes Butterfly iQ+ and iQ3 compatibility under the predicate PCCP.
FDA source Exact FDA submission Checked 2026-09-05
Adult cardiac acquisition assistance with compatible ultrasound systems and trained medical users; acquired views are assessed by qualified professionals. Version 1.3.0 adds an iPhone portrait interface while retaining the clinical acquisition functions.
FDA source Exact FDA submission Checked 2026-09-05
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
FDA submission
K260780
FDA source Exact FDA submission Checked 2026-08-31
The application performs its acquisition functions offline and stores medical data locally on the mobile device; the summary states that these data are not sent to a DESKi-controlled server. The change supports iPhone with iOS 17 or later, an A12 Bionic CPU and a minimum 4.7-inch display.
FDA source Exact FDA submission Checked 2026-09-05
This describes the cleared application boundary, not every connected PACS or enterprise export configuration.
Vendor confirmation Exact product version Checked 2026-09-05
K260780 describes application-level patient-data encryption patch HEAF-1578 and submission testing. A current scoped security attestation, retention policy and site-specific export data flow were not established; general FAQ compliance language is insufficient.
Training and support
Ultrasound basics and product training are required, provided by DESKi or a trained medical professional using approved materials.
FDA source Exact FDA submission Checked 2026-09-05
Vendor confirmation Exact product version Checked 2026-09-05
Ongoing acquisition-quality monitoring and post-update acceptance responsibilities are not established. Editorial acceptance questions: verify manual review, failed acquisition handling and successful PACS export on the installed probe and phone.
Current family connectivity requirements
The vendor FAQ describes offline scanning, online license verification every 30 days, and network access for installation, updates and DICOM export.
product family · checked 2026-09-05
Current public family documentation is not explicitly version-linked to K260780.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
The exact submission evaluates a mobile-platform modification and probe compatibility; historical family clinical evidence must be linked separately before applying it to v1.3.0.
FDA source Exact FDA submission Checked 2026-09-05
Reviewed sources checked Exact FDA submission Checked 2026-09-05
The reviewed exact-release summary reports acquisition and quality metrics, not a disease-detection sensitivity with an applicable clinical endpoint.
Reported specificity
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-05
A disease-detection specificity for HeartFocus v1.3.0 was not established by the reviewed summary.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
HeartFocus v1.3.0 Special 510(k) verification and validation
Simulated-use usability evaluation and historical-image AI validation, with software and cybersecurity verification. · Eight representative novice medical professionals with basic ultrasound training in a simulated iPhone/iQ3 workflow; separate historical validation used 40 US and 40 non-US patients.
exact submission · Tested version: HeartFocus v1.3.0 · Independence not established
K260780
No new clinical investigation for K260780. The historical-image cohort is distinct from the eight-participant usability evaluation; no diagnostic-outcome metric is inferred.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
The current HeartFocus pricing page lists $695 per license/year/probe or $1,800 per license/three years/probe for up to five licenses, with unlimited users. Enterprise plans for six or more licenses require a custom quote.
Vendor supplied Product family Checked 2026-09-06
The page uses a dollar symbol without an ISO currency designation and does not identify v1.3.0. This is a current family offer, not an exact-version quote; structured prices remain empty pending currency and contract confirmation.
Needs research Exact FDA submission Checked 2026-09-05
No applicable payer policy content was reviewed. Ultrasound service billing does not establish separate HeartFocus reimbursement.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify security and privacy controls: K260780 describes application-level patient-data encryption patch HEAF-1578 and submission testing. A current scoped security attestation, retention policy and site-specific export data flow were not established; general FAQ compliance language is insufficient.
Verify reimbursement and coding relevance: No applicable payer policy content was reviewed. Ultrasound service billing does not establish separate HeartFocus reimbursement.
Verify local validation and lifecycle monitoring: Ongoing acquisition-quality monitoring and post-update acceptance responsibilities are not established. Editorial acceptance questions: verify manual review, failed acquisition handling and successful PACS export on the installed probe and phone.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-06Last searched
17Fields reviewed
9Source classes checked
0Reviewed PubMed leads
1Reviewed trial leads
0Unreviewed FDA recall leads
Stored title PROSPECTIVE EVALUATION OF HEARTFOCUS and DESKi sponsor support a product-family lead. Exact tested version and registry results require full-record review; no trial performance promoted. The current discovery snapshot contains 0 PubMed and 1 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, vendor product page, vendor pricing observation, literature index, trial registry, pubmed, clinical trials, openfda device recall
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