Authorized purpose: 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 states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Guides medical professionals acquiring ten standard 2D transthoracic echocardiographic views in adults requiring a cardiac ultrasound examination; acquired images require qualified clinical interpretation.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Guides medical professionals acquiring ten standard 2D transthoracic echocardiographic views in adults requiring a cardiac ultrasound examination; acquired images require qualified clinical interpretation.
Which images or clinical context are in scope?Modality: Ultrasound Anatomy or clinical context: Heart/Cardiovascular Input: 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.
Who uses it?Intended users: Medical professionals trained in ultrasound basics and HeartFocus using DESKi training or approved materials delivered by a trained medical professional.
What does the software produce?Output: Probe-position guidance, image-quality feedback and recorded echocardiographic clips that the user can review and save.
What is its most important limitation?Key limitation: 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.
Clinical takeaway
Clinical role: Guides medical professionals acquiring ten standard 2D transthoracic echocardiographic views in adults requiring a cardiac ultrasound examination; acquired images require qualified clinical interpretation.
Evidence takeaway
Evidence from the reviewed source record: 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.
Clinical details
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.
Medical professionals trained in ultrasound basics and HeartFocus using DESKi training or approved materials delivered by a trained medical professional.
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.
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.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
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.
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.
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 ยท 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. Candidate literature without exact product and version linkage is not shown as product evidence.
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.
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
DesignSimulated-use usability evaluation and historical-image AI validation, with software and cybersecurity verification.
PopulationEight 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.
Scopeexact submission
Tested versionHeartFocus v1.3.0
IndependenceIndependence 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.
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
0Screened PubMed leads
1Screened 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
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history8 sources - 3 history items
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