# K191125: ADAS 3D

- Pathway: 510(k) (Traditional)
- Applicant: Galgo Medical S.L
- Decided: Jan 15, 2020 after 261 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 6 generations back to K940172 (1994). 19 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140587: MR-CT Vva, Medis Medical Imaging Systems BV (2015) Summary page 4.

## Most influential descendants
- K210850: ADAS 3D (2021), 4 descendants of its own
- K212421: ADAS 3D (2021), 3 descendants of its own
- K230803: ADAS 3D (2023), 2 descendants of its own
- K240791: ADAS 3D (2024), 1 descendant of its own
- K253969: ADAS 3D (2026), 0 descendants of its own

## 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 for use 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 for the visualization and analysis of cardiac images. 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. ADAS 3D is not intended to identify regions for catheter ablation or treatment of arrhythmias.

Source page: https://510kreport.com/device/K191125
Methodology: https://510kreport.com/methodology