# K253969: ADAS 3D

- Pathway: 510(k) (Traditional)
- Applicant: Adas3D Medical S.L.
- Decided: Jun 29, 2026 after 200 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K940172 (1994). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240791: ADAS 3D, Adas3D Medical S.L. (2024) Summary page 5.

## Indications for use
ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart on individual patients with cardiovascular disease. ADAS 3D is indicated for patients with myocardial scar produced by ischemic or non-ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D. ADAS 3D is indicated to be used only by qualified medical professionals (cardiologists, electrophysiologists, radiologists or trained technicians) for the calculation, quantification and visualization of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making. The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias (e.g., ventricular tachycardia) or risk stratification has not been established. ADAS 3D is not intended for radiotherapy treatment planning, dose calculation, or treatment delivery. The DICOM RT Structure Set (RTSTRUCT) export functionality is provided solely for interoperability and standardized exchange of anatomical contour information.

Source page: https://510kreport.com/device/K253969
Methodology: https://510kreport.com/methodology