510(k) · Radiology

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

by Elekta Solutions AB

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 that the U.S. FDA cleared through 510(k) K252188 on January 15, 2026. Its lead review panel is Radiology and its primary product code is IYE (Accelerator, Linear, Medical).

See also FDA-cleared AI radiology devices in 2026, all FDA AI clearances in 2026, top radiology AI devices.

Key facts

Submission numberK252188
Pathway510(k)
Date of final decision
Company (FDA list)Elekta Solutions AB
Lead review panelRadiology
Primary product codeIYE — Accelerator, Linear, Medical
Applicant (openFDA)Elekta Solutions AB
Applicant locationStockholm, SE
Device classClass 2
Regulation number21 CFR 892.5050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) went through this pathway (K252188).

openFDA lists it as a Class 2 device under 21 CFR 892.5050. Class II devices are moderate risk and are subject to general and special controls.

Product code IYE covers 3 devices on the FDA AI list. By decision date, this device is #3 of 3 under that code. Elekta Solutions AB has 3 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

Similar devices (product code IYE)

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