# K182076: Elekta Unity

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Limited
- Decided: Dec 4, 2018 after 125 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K010975 (2001). 41 ancestors in all.
3 later devices descend 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)
- K170751: MRIdian Linac System with 138-leaf Collimator, Viewray, Incorporated (2017) Summary page 4.

## Most influential descendants
- K192482: Elekta Unity (2019), 2 descendants of its own
- K212114: Elekta Unity (2021), 1 descendant of its own
- K223209: Elekta Unity (2023), 0 descendants of its own

## Recalls of this device
- Jun 24, 2019 · Class II · Z-1980-2019: The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.
- Apr 3, 2019 · Class II · Z-1297-2019: There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.
- Mar 12, 2019 · Class II · Z-1109-2019: Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the r
- Jan 4, 2019 · Class II · Z-0706-2019: In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislo

## 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 the 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. Images provide information that may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

Source page: https://510kreport.com/device/K182076
Methodology: https://510kreport.com/methodology