Elekta Synergy System

• • Terminated Z-3079-2011 FDA Unclassified (pre-2012) ·initiated 6 May 2011 ·on shared 510(k) K032996

  A small number of the Modular Reverse Diodes (D1A), a component in the equipment room of the Elekta Linear Accelerator, have ruptured.

• • Terminated Z-1441-2010 FDA Unclassified (pre-2012) ·initiated 18 Mar 2008

  Installation of a touchguard to prevent injury to patients or staff by stopping machine movements in the case of accidental collision.

• • Terminated Z-1159-2010 FDA Unclassified (pre-2012) ·initiated 1 Oct 2005

  Customer reported larger than expected variations in wedge factory with gantry rotation.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K032996 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Elekta Oncology Systems Icom/Quickmode Software Options

  Class II

  FDA 510(k) K973540 Active Cleared 17 Dec 1997

• Modification to: Viewgt Electronic Portal Imaging Device (Epid)

  Class II

  FDA 510(k) K012289 Active Cleared 14 Aug 2001

• Rt Desktop

  Class II

  FDA 510(k) K982713 Active Cleared 2 Nov 1998

• Iview Electronic Portal Imaging Device (Epid) Model Number Ivew

  Class II

  FDA 510(k) K981790 Active Cleared 7 Aug 1998