# K192442: FFRangio

- Pathway: 510(k) (Special)
- Applicant: Cathworks, Ltd.
- Decided: Dec 9, 2019 after 94 days
- Product code: QEK (Angiographic Coronary Vascular Physiologic Simulation Software)
- Device class: 2
- Regulation: 21 CFR 870.1415
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN130045 (2014). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182149: FFRangio System, Cathworks, Ltd. (2018) Summary page 4.

## Indications for use
CathWorks FFRangio™ is a software device for the clinical quantitative and qualitative analysis of previously acquired angiography DICOM data for patients with coronary artery disease. It provides FFRangio™, a mathematically derived quantity, computed from simulated blood flow information obtained from a 3D computer model, generated from coronary angiography images. FFRangio™ analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided as a supportive aid for qualified clinicians in the evaluation and assessment of coronary arteries physiology. The results of CathWorks FFRangio™ are intended to be used by qualified clinicians in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional evaluation.

Source page: https://510kreport.com/device/K192442
Methodology: https://510kreport.com/methodology