# K212114: Elekta Unity

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Solutions AB
- Decided: Oct 1, 2021 after 86 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K010975 (2001). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192482: Elekta Unity, Elekta Limited (2019) Summary page 4.

## Most influential descendants
- K223209: Elekta Unity (2023), 0 descendants of its own

## Recalls of this device
- Apr 6, 2023 · Class II · Z-1675-2023: There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.

## Indications for use
Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems. The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

Source page: https://510kreport.com/device/K212114
Methodology: https://510kreport.com/methodology