VEA Align

K231917

EOS imaging · cleared 2024-01-05 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“This cloud-based software is intended for orthopedic applications in both pediatric and adult populations.”

Algorithmmachine learning-based algorithm

source quote (p.4)

“The product uses biplanar 2D X-ray images, exclusively generated by EOS imaging's EOS (K152788) and EOSedge (K202394) systems and generates an initial placement of the patient anatomic landmarks on the images using a machine learning-based algorithm.”

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)

Retrospective clinical

n=555 patients

endpoints: algorithm performance met acceptance criteria

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

re_clearance
The FDA AI/ML device list shows a newer 510(k) K251747 (decision 2025-08-15) from EOS imaging for a matching device line ("VEA Align; spineEOS") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251747
re_clearance
The FDA AI/ML device list shows a newer 510(k) K240582 (decision 2024-06-25) from EOS imaging for a matching device line ("VEA Align; spineEOS") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K240582

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).