VEA Align; spineEOS

K240582

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

FDA 510(k) summary for VEA Align; spineEOS (K240582)

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
3
Performance observations
0
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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

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) 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_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.

Related FDA clearances

More AI/ML devices under product code QIH

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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syngo.CT Coronary Cockpit

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CMN Capillary Function with Oncology Virtual Expert

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Cercare Medical A/S

cleared 2026-06-22

Synapse PACS (7.6.0)

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FUJIFILM Healthcare Americas Corporation

cleared 2026-06-18

MediAI-OA

K253172

Crescom Co., Ltd.

cleared 2026-06-15

AiORTA - Plan v2.0

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cleared 2026-03-30

SwiftMR

K253775

Airs Medical, Inc.

cleared 2026-03-26

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