MEDO ARIA

K200356

Medo.ai · cleared 2020-06-11 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“MEDO ARIA is a cloud-based standalone software as a medical device (SaMD) that helps qualified users with image-based assessment of developmental hip dysplasia (DDH) of pediatric patients (e.g., ages 0 to 12 months).”

Algorithmmachine learning techniques

source quote (p.3)

“MEDO ARIA is designed to view and quantify ultrasound image data using machine learning techniques to aid trained medical professionals in diagnosis of developmental dysplasia of the hip (DDH).”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

standards: IEC 62304:2006/AC:2015, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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).