XVI R4.5

• • Terminated Z-1059-2014 FDA Class II ·initiated 25 Nov 2013

  XVI can incorrectly calculate the target position of the treatment table.

• • Terminated Z-1066-2012 FDA Not yet classified ·initiated 26 Jan 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, but the image panes continue to display the changed position.

• • Terminated Z-0342-2012 FDA Unclassified (pre-2012) ·initiated 20 Oct 2011

  A small number of sites have experienced situations with kV generator transformers overheating due to a diode failure on the interface board.

• • Terminated Z-0320-2012 FDA Unclassified (pre-2012) ·initiated 14 Oct 2011

  The software did not operate as expected.

1. 10 Mar 2010 Cleared FDA 510(k) K100115
2. 14 Oct 2011 Recall initiated FDA recalls Z-0320-2012
3. 20 Oct 2011 Recall initiated FDA recalls Z-0342-2012
4. 26 Jan 2012 Recall initiated FDA recalls Z-1066-2012
5. 25 Nov 2013 Recall initiated FDA recalls Z-1059-2014

510(k) Number

K100115 ↗

FDA product code

IYE

FDA applicant

Elekta , Ltd.

Device class

Class II

Regulation

21 CFR Part 892.5050

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

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