X1-FFR
FDA 510(k) K251355 · Spectrawave, Inc.
510(k) numberK251355
Submission
- Device name
- X1-FFR
- Applicant
- Spectrawave, Inc.
Bedford, MA, US - Received
- April 30, 2025
- Decision date
- October 17, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QHA – X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1600
- Specialty
- Radiology
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…
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Questions and answers
When was X1-FFR cleared by the FDA?
X1-FFR (K251355) received a 510(k) decision of Substantially Equivalent on October 17, 2025, 170 days after the submission was received.
What is the product code of K251355?
The FDA product code is QHA – X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device, a Class II (moderate risk) device regulated under 21 CFR 892.1600.