Radiology AI Directory

Vendor

Adas3D Medical S.L.

2 FDA submission entries in this directory. This is not a count of distinct commercial offers.

Claim vendor profile

Turn this list into an evaluation

Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

Prepare with a buyer guide:

Clinical guide links appear when this list contains a current reviewed example. They do not classify or endorse the other entries. All buyer guides · Compare exact records · Documented families

FDA-cleared K253969

ADAS 3D

Adas3D Medical S.L.

Authorized purpose: ADAS 3D supports visualization and analysis of MR and CT images of the heart for individual patients with cardiovascular disease, including patients with myocardial scar from ischemic or non-ischemic heart disease. Qualified professionals may use it for cardiac calculation, quantification, visualization, pre-planning, and electrophysiology procedures; produced data support clinical decision-making and must not be used as irrefutable medical advice or for radiotherapy planning, dose calculation, or treatment delivery.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Heart; myocardial scar and cardiac structures
Decision
2026-06-29
Cardiac imagingQuantification and segmentation
FDA-cleared K240791

ADAS 3D

Adas3D Medical S.L

Authorized purpose: ADAS 3D provides visualization, analysis, and quantification of MR and CT heart images in individual patients with cardiovascular disease, including myocardial scar assessment for pre-planning and during electrophysiology procedures.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Heart; myocardial scar and cardiovascular structures
Decision
2024-09-09
Cardiac imagingQuantification and segmentation