# K131965: XVI R5.0

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Limited
- Decided: Sep 25, 2013 after 90 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K926449 (1995). 35 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100115: XVI R4.5, Elekta, Ltd. (2010) Summary page 2.
- K123291: Truebeam, Varian Medical Systems, Inc. (2012) Summary page 1.
- K122451: Exactrac Vero, Brainlab AG (2012) Summary page 1.

## Most influential descendants
- K151561: Leksell Gamma Knife Icon (2015), 4 descendants of its own
- K160440: Leksell Gamma Knife Icon (2016), 3 descendants of its own
- K173789: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (2018), 2 descendants of its own
- K222047: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) (2022), 1 descendant of its own
- K161400: ImagingRing System (2016), 1 descendant of its own

## Indications for use
The Elekta X-Ray Volume Imaging system, XVI, is an electronic imaging device (EID), designed to be used with the Elekta range of medical linear accelerators and intended to be used as part of the radiation therapy treatment process for single or multiple fractions, of static and/or dynamic treatments, in gated or un-gated deliveries, in all areas of the body where such image guidance is determined by a licensed physician. It provides real-time 2D, 3D & 4D image guidance before, during and after treatment delivery, and is intended to support confirmation of patient positioning, monitoring and management of internal motion, and decision making in response to target position, size, shape and displacement resulting from organ deformation and anatomical movement in relation to surrounding critical structures. XVI facilitates precise and accurate dose placement, and patient set-up correction, through visualization of internal anatomy including target, critical structures and soft tissue with or without the use of implanted markers. Symmetry™ is a software option within XVI that can be used to acquire and display volumetric images of sequential phases of the breathing cycle for the evaluation of respiration induced motion, to assist in identification of appropriate target locations within anatomical structures in motion. The Elekta digital linear accelerator can be used for treatment that includes but is not limited to malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SBRT, prostate, and bone metastases.

Source page: https://510kreport.com/device/K131965
Methodology: https://510kreport.com/methodology