VEA Align; spineEOS

K240582

EOS imaging · cleared 2024-06-25 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“VEA Align is a software indicated for assisting healthcare professionals with global alignment assessment through clinical parameters computation. The product uses biplanar 2D X-ray images... and generates an initial placement of the patient anatomic landmarks on the images using a machine learning-based algorithm.”
Algorithmmachine learning-based algorithm / AI algorithm for initial placement and 3D model initialization
source quote (p.6)
“The product uses biplanar 2D X-ray images... and generates an initial placement of the patient anatomic landmarks on the images using a machine learning-based algorithm. Alignment mode: The 3D model supports the initial placement of the patient anatomic landmarks on the images using a machine learning-based algorithm. 3D mode: The 3D reconstruction model is initialized by an AI algorithm and then deformed manually by the user through control points up to matching accurately the X-ray contours.”
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)

Standalone

n=538 patients

endpoints: spinal landmark accuracy (Euclidean distance); spinal mesh accuracy (point to surface distance)

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
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

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 2026-07-08.

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).

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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K240582