Us2.v2

K233676

Eko.ai Pte. Ltd d/b/a Us2.ai · cleared 2024-04-01 · product code QIH · Radiology

FDA 510(k) summary for Us2.v2 (K233676)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
1
Performance observations
17
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Us2.v2 is an image post-processing analysis software device used for viewing and quantifying cardiovascular ultrasound images in DICOM format.”
AlgorithmMachine learning based view classification and border detection
source quote (p.5)
“Machine learning based view classification and border detection form the basis for this automated analysis.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
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=3,029 patients

endpoints: Root Mean Square Error (RMSE); Intraclass Correlation Coefficient (ICC)

standards: AAMI/ANSI HE75, Farsalinos et al., 2015

Reported performance (17 observations)

agreement_kappaas written: “LVOT Diameter ICC”0.78CI 0.77
source quote (p.9)
“LVOT Diameter (mm) 0.77 0.78”
agreement_kappaas written: “RV a' ICC”0.85CI 0.84
source quote (p.9)
“RV a' (cm/s) 0.84 0.85”
agreement_kappaas written: “RV e' ICC”0.86CI 0.85
source quote (p.9)
“RV e' (cm/s) 0.85 0.86”
agreement_kappaas written: “RV s' ICC”0.9CI 0.89
source quote (p.9)
“RV s' (cm/s) 0.89 0.90”
agreement_kappaas written: “TAPSE ICC”0.74CI 0.72
source quote (p.9)
“TAPSE (mm) 0.72 0.74”
agreement_kappaas written: “AoV Pmax ICC”0.96CI 0.95
source quote (p.9)
“AoV Pmax (mmHg) 0.95 0.96”
agreement_kappaas written: “AoV Pmean ICC”0.98CI 0.97
source quote (p.9)
“AoV Pmean (mmHg) 0.97 0.98”
agreement_kappaas written: “AoV Vmax ICC”0.98CI 0.98
source quote (p.9)
“AoV Vmax (m/s) 0.98 0.98”
agreement_kappaas written: “AoV VTI ICC”0.97CI 0.96
source quote (p.9)
“AoV VTI (cm) 0.96 0.97”
agreement_kappaas written: “AVA ICC”0.82CI 0.78
source quote (p.9)
“AVA (cm^2) 0.78 0.82”
agreement_kappaas written: “LVOT Pmax ICC”0.9CI 0.88
source quote (p.9)
“LVOT Pmax (mmHg) 0.88 0.90”
agreement_kappaas written: “LVOT Pmean ICC”0.91CI 0.90
source quote (p.9)
“LVOT Pmean (mmHg) 0.90 0.91”
agreement_kappaas written: “LVOT Vmax ICC”0.92CI 0.91
source quote (p.9)
“LVOT Vmax (m/s) 0.91 0.92”
agreement_kappaas written: “LVOT VTI ICC”0.91CI 0.89
source quote (p.9)
“LVOT VTI (cm) 0.89 0.91”
agreement_kappaas written: “VR ICC”0.94CI 0.93
source quote (p.9)
“VR 0.93 0.94”
agreement_kappaas written: “Sinotub Junction ICC”0.78CI 0.74
source quote (p.9)
“Sinotub Junction (mm) 0.74 0.78”
agreement_kappaas written: “Sinus Valsalva ICC”0.82CI 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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
drift signals on this device
  • 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_reason_pattern

    Software/algorithm-related recall in product code QIH (PIE Medical Imaging B.V., initiated 2026-05-07): "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:98930

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 2026-08-26.

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 Radiology 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.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K233676