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.”

Algorithmmachine-learning-based features for standard initialization of various cardiac structures from CT and MRI images

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 (2)

Retrospective clinical

n=796 images

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).