Us2.v1
K210791eko.ai Pte. Ltd. d/b/a Us2.ai · cleared 2021-07-27 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Us2.v1 is an image post-processing analysis software device used for viewing and quantifying cardiovascular ultrasound images in DICOM format.”
source quote (p.5)
“Machine learning based view classification and border detection form the basis for this automated analysis.”
source quote (p.7)
“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=600 cases
endpoints: reference-scaled individual equivalence coefficient (IEC)
standards: AAMI/ANSI HE75
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K250151 (decision 2025-06-20) from Eko.Ai Pte Ltd. D/B/A Us2.Ai for a matching device line ("Us2.ca") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250151
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K233676 (decision 2024-04-01) from Eko.ai Pte. Ltd d/b/a Us2.ai for a matching device line ("Us2.v2") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233676
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).