# K230303: AccuFFRangio Plus

- Pathway: 510(k) (Special)
- Applicant: ArteryFlow Technology Co., Ltd.
- Decided: Mar 2, 2023 after 27 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: 17 generations back to K926514 (1993). 101 ancestors in all.
No later device cites it as a predicate yet.
1 of 102 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210093: AccuFFRangio, ArteryFlow Technology Co., Ltd. (2021) Summary page 4.

## Indications for use
AccuFFRangio Plus is indicated for use in clinical settings where validated and repreproducible 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 AccuFFRangio Plus 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/K230303
Methodology: https://510kreport.com/methodology