Rapid Aortic Measurements

K251987

iSchemaView, Inc. · cleared 2025-09-23 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Rapid Aortic Measurements (AM) is a Software as a Medical Device (SaMD) image processing module and is part of the Rapid Platform.”
AlgorithmAI/ML; traditional image analysis and measurement device that segments aorta, iliacs, and major branching vessels, provides 2D/3D visualizations (VRs, CPRs, MPRs), vessel centerlines, and measurements.
source quote (p.4)
“Rapid Aortic Measurements (AM) is an image analysis and measurement device to evaluate aortic and iliac arteries in contrast enhanced and non-contrast CT imaging datasets acquired of the chest, abdomen, and/ or pelvis. The module segments the aorta, iliacs, and major branching vessels and provides 2D and 3D visualizations of the segmented vessels.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.9)
“Rapid Aortic Measurements has been designed to meet the cybersecurity requirements using design Vulnerability Assessments, SBOM's, and PEN Testing.”

Validation studies (2)

Retrospective clinical

n=115 patients

endpoints: segmentation quality/clinical accuracy; CPR/MPR quality; anatomical labeling; maximum oblique diameter location accuracy; longitudinal results

Retrospective clinical

n=108 cases

endpoints: Dice coefficient; Hausdorff distance; mean absolute error (MAE); reproducibility of generating ground truths

Reported performance (2 observations)

diceas written: “Dice coefficient (VR outputs)”0.93
source quote (p.10)
“For VR outputs, the primary endpoint passed with an average Dice coefficient of 0.93”
diceas written: “Dice coefficient (reproducibility of generating ground truths)”0.95
source quote (p.10)
“The secondary endpoint, reproducibility of generating ground truths, showed an average Dice coefficient of 0.95, demonstrating strong reproducibility of ground truth segmentations.”

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
0
drift signals on this device

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/K251987