K231612
- 510(k) number
- K231612
- Device name
- Eve Patient Positioner System
- Applicant
- Leo Cancer Care WI · US
- Product code
- JAI — Couch, Radiation Therapy, Powered
- Decision date
- 2024-05-07
- Date received
- 2023-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K231612.pdf
Official FDA record: K231612
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.