EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)

Elekta Solutions AB · K252188 · 2026-01-15

EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) is an AI-enabled medical device from Elekta Solutions AB, listed by FDA (510(k), K252188) with a decision date of 2026-01-15. Review panel: Radiology.

FDA submission numberK252188
Pathway510(k)
CompanyElekta Solutions AB
Review panel (specialty)Radiology
FDA decision date2026-01-15
DecisionSubstantially Equivalent
Product codeIYE
ClassificationAccelerator, Linear, Medical
Device class2
Regulation number892.5050
Review time (calendar days)185
Applicant countrySE

Official FDA database record · FDA AI-enabled device list

More devices from Elekta Solutions AB · All Radiology AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.