K251355 is an FDA 510(k) clearance for the X1-FFR. This device is classified as a X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device (Class II - Special Controls, product code QHA).
Submitted by Spectrawave, Inc. (Bedford, US). The FDA issued a Cleared decision on October 17, 2025, 170 days after receiving the submission on April 30, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Is A Prescription Device That Provides An Image Analysis Tool To Assess Blood Flow In The Coronary Vascular System Using X-ray Angiographic Imaging Data. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Solves Algorithms And Yields Simulation-based Metrics For Certain Cardiology Applications. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Cannot Be Used Alone For Clinical Decision Making And Clinical Management, And Is A Tool Intended To Generate Results For Use And Review By A Qualified Clinician..
| 510(k) Number | K251355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2025 |
| Decision Date | October 17, 2025 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | QHA - X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |
| Definition | X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Is A Prescription Device That Provides An Image Analysis Tool To Assess Blood Flow In The Coronary Vascular System Using X-ray Angiographic Imaging Data. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Solves Algorithms And Yields Simulation-based Metrics For Certain Cardiology Applications. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Cannot Be Used Alone For Clinical Decision Making And Clinical Management, And Is A Tool Intended To Generate Results For Use And Review By A Qualified Clinician. |