K251355
- 510(k) number
- K251355
- Device name
- X1-FFR
- Applicant
- Spectrawave, Inc. MA · US
- Product code
- QHA — X-Ray Angiographic Imaging Based Coronary Vascular S
- Decision date
- 2025-10-17
- Date received
- 2025-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K251355.pdf
Official FDA record: K251355
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.