ADAS 3D

K240791

Adas3D Medical S.L · cleared 2024-09-09 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“ADAS 3D is a stand-alone software tool intended to be used for post-processing cardiovascular enhanced Magnetic Resonance (MR) images and Computed Tomography Angiography (CTA) images that are formatted in the Digital Imaging and Communication in Medicine (DICOM) standard.”
AlgorithmSemi-automatic using Machine Learning technique for various initialization tasks.
source quote (p.6)
“Additionally, ADAS 3D uses the following machine-learning-based features: Standard Initialization of the LV, LA, and Aorta from CTA; Standard Initialization of the Coronary Arteries from CTA; Standard Initialization of the LA from CTA; Standard Initialization of the LV from 2D LGE-MRI and Automatic Slice Alignment; Standard Initialization of the LV from 3D LGE-MRI; Standard Initialization of the LA from 3D LGE-MRI”
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=665 cases

endpoints: MSD: Mean Surface Distance; HD: Hausdorff Distance; MDS: Mean Difference in Shifts; APD: Average Perpendicular Distance; DC: Dice Metric; CA: Color agreement; CD1: Color disagreement by one color; CD2: Color disagreement by two colors or more

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
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/K240791