K243769
- 510(k) number
- K243769
- Device name
- QFR (3.0)
- Applicant
- Qfr Solutions BV NL
- Product code
- QHA — X-Ray Angiographic Imaging Based Coronary Vascular S
- Decision date
- 2025-04-04
- Date received
- 2024-12-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243769.pdf
Official FDA record: K243769
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.