# K182611: Qangio XA 3D

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: May 30, 2019 after 251 days
- Product code: QHA (X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K926514 (1993). 99 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 104 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180019: CAAS Workstation, Pie Medical Imaging BV (2018) Summary page 4.

## Most influential descendants
- K210093: AccuFFRangio (2021), 2 descendants of its own
- K243769: QFR (3.0) (2025), 0 descendants of its own
- K230303: AccuFFRangio Plus (2023), 0 descendants of its own
- K221711: AccuICAS (2023), 0 descendants of its own

## Indications for use
QANGIO XA 3D is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease. When the quantified results provided by QAngio XA 3D are used in a clinical setting on X-ray images of an individual patient. The results are only intended for use by the responsible clinicians.

Source page: https://510kreport.com/device/K182611
Methodology: https://510kreport.com/methodology