HeartFocus (V.1.1.1)
K242807Deski · cleared 2025-04-04 · product code QJU · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The HeartFocus software is a radiological computer-assisted acquisition guidance system that provides real-time user guidance during echocardiography to assist the user in acquiring anatomically standard diagnostic-quality 2D echocardiographic views. HeartFocus software is an accessory to compatible general-purpose diagnostic ultrasound systems.”
source quote (p.6)
“HeartFocus uses artificial intelligence (AI) to emulate the expertise of sonographers in positioning the probe on the patient's chest and in identifying and recording diagnostic-quality clips.”
source quote (p.21)
“M1 - Retraining of the core algorithms: This modification's scope is the retraining of the AI/ML models in the perspective of validating a new manufacturer prior to an M2. The modification is limited to retraining with additional data without changing the models' architecture or training procedure.”
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
source quote (p.6)
“HeartFocus is an application that operates entirely offline, without requiring a cloud server to provide its functionalities. All collected medical data is stored locally on the tablet. This data is never transferred to a server controlled by DESKi.”
Validation studies (3)
Bench
n=31 other
endpoints: Success rate of critical tasks
standards: FDA Guidance Document, « Applying Human Factors and Usability Engineering to Medical Devices », IEC 62366 1:205 standard
Standalone
n=290 patients
endpoints: Cohen's kappa score; Positive predictive value of successful guidance cues; Positive predictive value of high-quality records
Prospective clinical
n=240 patients · 2 site(s)
endpoints: Qualitative Visual Assessment of LV Size; Qualitative Visual Assessment of LV Function; Qualitative Visual Assessment of RV Size; Qualitative Visual Assessment of Non-Trivial Pericardial Effusion
Reported performance (5 observations)
source quote (p.15)
“Cohen's kappa scores range from 0.699 [0.673, 0.724] to 0.873 [0.861, 0.884], meeting the success criteria of Cohen's kappa score > 0.6 on the lower bound of the 95% CI for each reference view.”
source quote (p.15)
“Guidance cues PPV ranges from 0.810 [0.804, 0.816] to 0.953 [0.951, 0.955], satisfying the success criteria of PPV > 0.8 on the lower bound of the 95% CI for each reference view.”
source quote (p.15)
“While using the Auto record feature solely, the PPV ranges from 0.846 [0.665, 0.938] to 1.000 [0.908, 1.000], meeting the success criteria of PPV > 0.6 on the lower bound of the 95% CI and PPV > 0.8 on the point estimate for each reference view.”
source quote (p.15)
“While using both the Auto record and Best-Effort record, the PPV ranges from 0.816 [0.666, 0.908] to 1.000 [0.914, 1.000].”
source quote (p.20)
“99.7% of the clips recorded with the “Auto record” feature were of diagnostic quality, demonstrating the high specificity of this feature.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).