# K100115: XVI R4.5

- Pathway: 510(k) (Traditional)
- Applicant: Elekta, Ltd.
- Decided: Mar 10, 2010 after 54 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: 3 generations back to K963624 (1996). 3 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051932: Elekta Synergy; Elekta Synergy S and XVIR3.5, Elekta, Inc. (2005) Summary page 1.

## Most influential descendants
- K131965: XVI R5.0 (2013), 8 descendants of its own
- 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

## Recalls of this device
- Nov 25, 2013 · Class II · Z-1059-2014: XVI can incorrectly calculate the target position of the treatment table.
- Jan 26, 2012 · Not classified · Z-1066-2012: If a user, using an on-line correction protocol, clicks the accept correction button, an approval dialog box appears. If cancel is selected, the table correction values return to their initial values,
- Oct 20, 2011 · Not classified · Z-0342-2012: A small number of sites have experienced situations with kV generator transformers overheating due to a diode failure on the interface board.
- Oct 14, 2011 · Not classified · Z-0320-2012: The software did not operate as expected.

## 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 radiation therapy treatment process, as determined by a licensed medical practitioner. XVI, is intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement. 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.

Source page: https://510kreport.com/device/K100115
Methodology: https://510kreport.com/methodology