K240398
- 510(k) number
- K240398
- Device name
- RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
- Applicant
- RaySearch Laboratories AB (PUBL) SE
- Product code
- MUJ — System, Planning, Radiation Therapy Treatment
- Decision date
- 2025-04-04
- Date received
- 2024-02-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K240398.pdf
Official FDA record: K240398
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.