K252188
- 510(k) number
- K252188
- Device name
- EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
- Applicant
- Elekta Solutions AB SE
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2026-01-15
- Date received
- 2025-07-14
- 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: K252188.pdf
Official FDA record: K252188
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.