# K251355: X1-FFR

- Pathway: 510(k) (Traditional)
- Applicant: Spectrawave, Inc.
- Decided: Oct 17, 2025 after 170 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.
No later device cites it as a predicate yet.
1 of 100 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 5.

## Indications for use
The SpectraWAVE X1-FFR Software features segmentation of coronary vessels, and measurement and reporting tools to facilitate the following use: • Calculate the dimensions of coronary vessels; • Quantify stenosis in coronary vessels; • Quantify pressure drop in coronary vessels; The SpectraWAVE X1-FFR Software is intended to be used by or under the supervision of a cardiologist.

Source page: https://510kreport.com/device/K251355
Methodology: https://510kreport.com/methodology