K250902
- 510(k) number
- K250902
- Device name
- HeartFlow Analysis
- Applicant
- HeartFlow, Inc. CA · US
- Product code
- PJA — Coronary Vascular Physiologic Simulation Software
- Decision date
- 2025-07-18
- Date received
- 2025-03-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250902.pdf
Official FDA record: K250902
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.