K252109
- 510(k) number
- K252109
- Device name
- RayStation (2024A SP3)
- Applicant
- RaySearch Laboratories AB (PUBL) SE
- Product code
- MUJ — System, Planning, Radiation Therapy Treatment
- Decision date
- 2025-12-22
- Date received
- 2025-07-07
- 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: K252109.pdf
Official FDA record: K252109
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.