K252002
- 510(k) number
- K252002
- Device name
- Monaco RTP System (6.3)
- Applicant
- Elekta Solutions AB SE
- Product code
- MUJ — System, Planning, Radiation Therapy Treatment
- Decision date
- 2026-02-19
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252002.pdf
Official FDA record: K252002
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.