K243808
- 510(k) number
- K243808
- Device name
- Rayvolve PTX-PE
- Applicant
- AZmed FR
- Product code
- QFM — Radiological Computer-Assisted Prioritization Softwa
- Decision date
- 2025-03-21
- Date received
- 2024-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243808.pdf
Official FDA record: K243808
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.