Devices · Elekta Solutions AB

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

Elekta Solutions AB is listed for EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) (K252188). The FDA list gives January 15, 2026 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is IYE. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252188

Official FDA database record

Date of final decision

January 15, 2026

Company on the FDA list

Elekta Solutions AB

Lead panel

Radiology

Primary product code

IYE

openFDA device name for the code

Accelerator, Linear, Medical

Device class

2

Regulation number

892.5050

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary