Us2.ca

K250151

Eko.Ai Pte Ltd. D/B/A Us2.Ai · cleared 2025-06-20 · product code SDJ · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.8)
“SaMD Yes”
AlgorithmAI-derived measurements, video-based deep-learning approach
source quote (p.6)
“The Us2.ai platform is a clinical decision support tool that analyzes echocardiogram images in order to generate a series of AI-derived measurements. Us2.ca uses a video-based deep-learning approach for CA detection.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.11)
“A Cybersecurity Analysis and data security testing were conducted to verify that data and patient protected health information security measures are included in the design of the software.”

Validation studies (1)

Retrospective clinical

n=1,647 patients · 6 site(s)

endpoints: sensitivity; specificity

Reported performance (2 observations)

sensitivity86.9CI 84.2%-89.7%
source quote (p.13)
“Us2.ca performed with a sensitivity of 86.9% (95% CI: 84.2%-89.7%)”
specificity87.4CI 85.2%-89.7%
source quote (p.13)
“and specificity of 87.4% (95% CI: 85.2%-89.7%).”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K250151