K232854
- 510(k) number
- K232854
- Device name
- Leksell GammaPlan (LGP)
- Applicant
- Elekta Solutions AB SE
- Product code
- IWB — System, Radiation Therapy, Radionuclide
- Decision date
- 2024-02-08
- Date received
- 2023-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232854.pdf
Official FDA record: K232854
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.