AiORTA - Plan

K250337

ViTAA Medical Solutions, Inc. · cleared 2025-10-30 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The AiORTA - Plan tool is an image analysis software tool for volumetric assessment.”
AlgorithmAI-powered auto-masking algorithm
source quote (p.6)
“Segmentation: an Al-powered auto-masking algorithm performs segmentation of the aortic lumen, wall, and key anatomical landmarks, including the superior mesenteric, celiac, and renal arteries.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.12)
“Cybersecurity testing included verification and validation of cybersecurity controls including manual and automated testing, vulnerability testing, and penetration testing. Post-market monitoring processes have been established to detect and address new vulnerabilities.”

Validation studies (3)

Reader study (MRMC)

sample size not stated

endpoints: Dice coefficient for aortic wall and aortic lumen masks; Key anatomical landmarks identification within 5mm of ground truth

Reader study (MRMC)

sample size not stated

endpoints: Comparison of diameters and lengths against radiologists' annotations

Bench

n=40 scans

endpoints: Mean absolute error for Volume of the Wall; Mean absolute error for Volume of the Lumen

Reported performance (2 observations)

diceas written: “Overall Mean Dice coefficient for the aortic wall”0.89
source quote (p.10)
“Overall Mean Dice coefficient of 89% achieved for the aortic wall”
diceas written: “Overall Mean Dice coefficient for the aortic lumen masks”0.89
source quote (p.10)
“Overall Mean Dice coefficient of 89% achieved for the aortic lumen masks”

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) K254207 (decision 2026-03-30) from ViTAA Medical Solutions, Inc. for a matching device line ("AiORTA - Plan v2.0") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K254207

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/K250337