# K032996: Elekta Synergy System

- Pathway: 510(k) (Special)
- Applicant: Elekta Oncology Systems, Ltd.
- Decided: Oct 23, 2003 after 28 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963624 (1996). 1 ancestor in all.
85 later devices descend from it; 3 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963624: Philips Sli Series Linear Accelerator, Philips Medical Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K040192: ON-Board Imager Device (2004), 79 descendants of its own
- K042720: ON-Board Imager Device (2004), 76 descendants of its own
- K092871: Trilogy MX (2009), 61 descendants of its own
- K111106: Truebeam (2011), 43 descendants of its own
- K123291: Truebeam (2012), 37 descendants of its own

## Recalls of this device
- May 6, 2011 · Not classified · Z-3079-2011: A small number of the Modular Reverse Diodes (D1A), a component in the equipment room of the Elekta Linear Accelerator, have ruptured.
- Mar 18, 2008 · Not classified · Z-1441-2010: Installation of a touchguard to prevent injury to patients or staff by stopping machine movements in the case of accidental collision.
- Oct 1, 2005 · Not classified · Z-1159-2010: Customer reported larger than expected variations in wedge factory with gantry rotation.

## Indications for use
The Elekta Synergym System is intended to be used for radiation therapy treatment of malignant neophstic diseases, as determinedby a licensed medical practitioner.

Source page: https://510kreport.com/device/K032996
Methodology: https://510kreport.com/methodology