Us2.v2
K233676Eko.ai Pte. Ltd d/b/a Us2.ai · cleared 2024-04-01 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyze and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/ right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities.”
source quote (p.5)
“Machine learning based view classification and border detection form the basis for this automated analysis.”
source quote (p.8)
“Cybersecurity Analysis and Data Security testing were conducted to ensure that robust measures for safeguarding data and protected health information of patients are included into the software design.”
Validation studies (1)
Retrospective clinical
n=3,481 patients
endpoints: Global Longitudinal Strain; Regional Longitudinal Strain; LVOT Diameter; RV a'; RV e'; RV s'; TAPSE; AoV Pmax; AoV Pmean; AoV Vmax; AoV VTI; AVA; LVOT Pmax; LVOT Pmean; LVOT Vmax; LVOT VTI; VR; Sinotub Junction; Sinus Valsalva
Reported performance (17 observations)
source quote (p.9)
“LVOT Diameter (mm) 0.77 0.78”
source quote (p.9)
“RV a' (cm/s) 0.84 0.85”
source quote (p.9)
“RV e' (cm/s) 0.85 0.86”
source quote (p.9)
“RV s' (cm/s) 0.89 0.90”
source quote (p.9)
“TAPSE (mm) 0.72 0.74”
source quote (p.9)
“AoV Pmax (mmHg) 0.95 0.96”
source quote (p.9)
“AoV Pmean (mmHg) 0.97 0.98”
source quote (p.9)
“AoV Vmax (m/s) 0.98 0.98”
source quote (p.9)
“AoV VTI (cm) 0.96 0.97”
source quote (p.9)
“AVA (cm^2) 0.78 0.82”
source quote (p.9)
“LVOT Pmax (mmHg) 0.88 0.90”
source quote (p.9)
“LVOT Pmean (mmHg) 0.90 0.91”
source quote (p.9)
“LVOT Vmax (m/s) 0.91 0.92”
source quote (p.9)
“LVOT VTI (cm) 0.89 0.91”
source quote (p.9)
“VR 0.93 0.94”
source quote (p.9)
“Sinotub Junction (mm) 0.74 0.78”
source quote (p.9)
“Sinus Valsalva (mm) 0.78 0.82”
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
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).