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

🇸🇪Elekta Solutions AB · Accelerator, Linear, Medical

What it does

Supports the imaging workflow around multi-modality studies — routing, scheduling, or image management — rather than interpreting the images.

Who it's for

Imaging departments and informatics teams managing study flow.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.

Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.

FDA

Pathway510(k)

Submission #K252188

Product codeIYE

Decision dateJan 15, 2026

PanelRadiology

FDA recordaccessdata

EU (CE)

Statusunknown

Risk class—

Notified body—

EMDN code—

Basic UDI-DI—

AI Act class—

EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.

Vendor

Company🇸🇪Elekta Solutions AB

Foundedunknown

Cite this page

RadPigeon. "EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) (Elekta Solutions AB)." AI Devices registry. https://radpigeon.news/ai/device/emla-elekta-evo-emla-versahd-emla-elekta-harmony-pro-emla-elekta-infintiy-emla-e

Last updated Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.