Elekta Oncology Systems Precise Treatment Table

• • Terminated Z-1238-2015 FDA Class II ·initiated 29 Jan 2015

  It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may occur if a position error is not detected.

• • Terminated Z-1072-2013 FDA Class II ·initiated 14 Mar 2013

  The Column rotation can accidentally be moved to a different position which in the locked position.

• • Terminated Z-1030-2011 FDA Unclassified (pre-2012) ·initiated 10 Mar 2008

  Possible error in the table longitudinal position.

• • Terminated Z-1432-2010 FDA Unclassified (pre-2012) ·initiated 11 Jan 2007

  In some instances, the bolts which are supplied with the table have sheared off, resulting in inability to operate the powered table.

510(k) Number

K983678 ↗

FDA Product Code

JAI

Device Class

Class II

Regulation

21 CFR Part 892.5770

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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