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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Elekta Evo Linear Accelerator With Machine-Learning Image Reconstruction

The radiation therapy system, already CE marked in Europe, adds a high-definition CT reconstruction option for the pelvis that uses a neural network to estimate and remove scatter.

By News DeskJanuary 21, 20262 min read
An Elekta Compact radiation therapy linear accelerator with its treatment couch
An Elekta Compact linear accelerator in a treatment room. Not the Elekta Evo described in this article. Narenfox, CC BY-SA 4.0, via Wikimedia Commons · CC BY-SA 4.0
FDA cleared510(k) · K252188FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared Elekta's linear accelerator family, including the Evo model, under 510(k) K252188 on January 15, 2026; Elekta announced it on January 16.
  • The new high-definition cone-beam CT reconstruction, sold as Iris, is limited for now to pelvic anatomy and is also available on Versa HD and Harmony Pro.
  • The 510(k) summary says no animal or clinical tests were performed; image comparisons used phantoms and clinical data sets.

The US Food and Drug Administration has cleared Elekta's Evo linear accelerator, a radiation therapy machine whose onboard imaging uses machine learning to sharpen the CT scans taken before each treatment, the Swedish company said in a regulatory release on January 16, read via Inderes. Elekta said the clearance makes the system available to radiation oncology professionals in the United States.

The FDA's 510(k) database lists the clearance as K252188, covering the Elekta Medical Linear Accelerator in six models: Evo, Versa HD, Harmony Pro, Infinity, Harmony and Synergy. The agency received the submission on July 14, 2025, and found it substantially equivalent on January 15, 2026.

What changed

According to the clearance letter and 510(k) summary, the predicate is Elekta's own earlier linear accelerator clearance, K210500, and the indications for use are the same. Evo and Versa HD are the high-level configurations, intended for standard and stereotactic treatments, including stereotactic radiosurgery, and for functional disorders such as trigeminal neuralgia. The system is indicated for curative and palliative external beam radiation therapy in adults and children.

The main change is a new cone-beam CT reconstruction pipeline on Evo, Versa HD and Harmony Pro, which Elekta markets as Iris. The summary says it uses an iterative reconstruction method and a scatter correction "using a machine learning method where a neural network is trained to estimate scatter in the projection domain." For now it is supported only in pelvic anatomies, and users can choose between it and the existing reconstruction method.

The summary says image quality was compared with the existing method on phantoms and on 124 clinical data sets, and registration accuracy on 13 clinical patient data sets. It reports improved uniformity and Hounsfield unit accuracy in the pelvis. It states that no animal or clinical tests were performed to establish substantial equivalence.

What Elekta says

Elekta said that, unlike conventional cone-beam CT imaging, Evo uses AI to reduce scatter and enhance image reconstruction, and that Iris can be added as an upgrade to some existing Elekta linear accelerators depending on the version.

"Securing FDA clearance for Elekta Evo is a pivotal step in our commitment to the U.S. market," said Ardie Ermers, Elekta's executive vice president for the Americas, in the release.

Eenas Omari of the radiation oncology team at the Medical College of Wisconsin, which was involved in developing Iris, said in the release that it brings a reduction in artifacts and improved soft tissue contrast. Trade outlet DOTmed reported on January 21 that Evo received a CE mark in Europe before the FDA clearance and is already in clinical use in several markets outside the US. Elekta did not disclose US pricing.

Sources

  1. Elekta receives FDA 510(k) clearance for Elekta Evo linear accelerator (regulatory release, read via Inderes), Elekta via Inderes, January 16, 2026
  2. 510(k) K252188: Elekta Medical Linear Accelerator (Elekta Evo and other models) (database record), US Food and Drug Administration, January 15, 2026
  3. K252188 clearance letter and 510(k) summary, US Food and Drug Administration, January 15, 2026
  4. Elekta Evo linear accelerator receives FDA clearance, DOTmed, January 21, 2026