X1-FFR is an AI-enabled medical device from Spectrawave, Inc. that the U.S. FDA cleared through 510(k) K251355 on October 17, 2025. Its lead review panel is Radiology and its primary product code is QHA (X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device).
See also FDA-cleared AI radiology devices in 2025, all FDA AI clearances in 2025, top radiology AI devices.
Key facts
| Submission number | K251355 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Spectrawave, Inc. |
| Lead review panel | Radiology |
| Primary product code | QHA — X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device |
| Applicant (openFDA) | Spectrawave, Inc. |
| Applicant location | Bedford, MA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.1600 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. X1-FFR went through this pathway (K251355).
openFDA lists it as a Class 2 device under 21 CFR 892.1600. Class II devices are moderate risk and are subject to general and special controls.
Product code QHA covers 2 devices on the FDA AI list. By decision date, this device is #2 of 2 under that code. Spectrawave, Inc. has 1 AI-enabled device on the list, and the Radiology panel accounts for 1,230 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.