510(k) K252188 ยท IYE Accelerator, Linear, Medical
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
| Applicant | Elekta Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Jan 15, 2026 |
| Received | Jul 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252188
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.