Radiology · 510(k) · 2026
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
Elekta Solutions AB. Cleared by FDA on 15 January 2026 under submission K252188, product code IYE (accelerator, linear, medical). What FDA's record says, in FDA's words.
Device record · K252188
- Device. EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)DEVICE
- Company. Elekta Solutions AB (SE)COMPANY
- Decision. 15 January 2026, 510(k), substantially equivalent (traditional review); received 14 July 2025DECISION
- Panel. RadiologyPANEL
- Product code. IYE, Accelerator, Linear, MedicalCODE
- Regulation. 21 CFR 892.5050, Class IIREG
- Source. FDA database entry · decision document (15 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licensed medical practitioner. It is intended to assist a licensed medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. Elekta Synergy and Elekta Harmony are the default entry-level configurations. It is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, and hypofractionation in all areas of the body where such treatment is indicated. Elekta Infinity and Elekta Harmony Pro are the default mid-level configuration. It is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy – SBRT; stereotactic ablative radiotherapy – SABR) in all areas of the body where such treatment is indicated. Versa HD and Elekta Evo are the default high-level configuration. It is intended to be used for single or multiple fractions using standard fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy – SBRT; stereotactic ablative radiotherapy – SABR; stereotactic radio surgery - SRS) in all areas of the body where such treatment is indicated and for the treatment of functional disorders, such as trigeminal […]
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 3,077 reports filed against devices carrying product code IYE. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
24 September 2026 · Malfunction · Elekta Synergy · Elekta Solutions AB · report 3015232217-2026-00033
The customer reported that they were not able to perform table shift movements during treatment. The table hight was stuck above standing height.
17 September 2026 · Malfunction · Elekta Medical Linear Accelerator (EMLA) · Elekta Solutions AB · report 3015232217-2026-00032
Elekta has internally identified braze overflow into the internal cavities of the waveguide cells in the manufacturing process for assembling of machined waveguide cells. This can lead to dark current on Elekta Medical Linear Accelerators.
14 September 2026 · Other · MOSAIQ · Elekta Solutions AB · report 3015232217-2026-00029
The customer reported that the Cone Beam Computed Tomography (CBCT) was taken. However, the system did not record the CBCT as having been completed.
3 September 2026 · Malfunction · Elekta Synergy · Elekta Solutions AB · report 3015232217-2026-00028
The customer reported that a fire developed in the modulator area.
28 August 2026 · Malfunction · Radixact Treatment Delivery System · Accuray Incorporated · report 3003873069-2026-00002
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code IYE, in Radiology, from Elekta Solutions AB, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.