Modification to: Hi-Art System

• • Terminated Z-2243-2009 FDA Unclassified (pre-2012) ·initiated 10 Aug 2009 ·on shared 510(k) K060912

  TomoTherapy received one customer report indicating that after starting a patient procedure from the Status Console, the radiation on light and the audible indicator on the Status Console came on as expected, however the Operator Station (OS) did not display the dose rate and the procedure time, or the couch position updates. Within a few minutes, the customer pressed the Stop button on the Sta

• • Terminated Z-0628-2009 FDA Unclassified (pre-2012) ·initiated 14 Oct 2008

  TomoTherapy Incorporated identified a potential issue with the Hi-Art system during the course of ongoing testing. The Operator Station Calibration panel provides access to view and modify machine specific configuration settings. Access to these settings has always been restricted to individuals with appropriate security rights, being limited to only the "Superuser" and "Field Service engine

• • Terminated Z-0339-2009 FDA Unclassified (pre-2012) ·initiated 18 Sep 2008

  TomoTherapy Inc. discovered an issue on the Hi-Art system during the course of ongoing testing. It has been identified that treatment plans involving very small structures (volume <2cc), reading in a high dose gradient region, may exhibit inaccuracies with the DVH curve and the Dose Statistics for the small structures. This error can only happen if planning was performed using very small voxels

• • Terminated Z-1615-2008 FDA Unclassified (pre-2012) ·initiated 22 Feb 2008

  Registration adjustment field numbers may appear on printed pages of the Register Tab as nonsense characters or values different than the numbers shown on the Operator Station (OS) display. Setup will move the couch to the correct offset position. If the couch is manually adjusted to the incorrect value, the patient may not be the correct position during treatment.

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

510(k) Number

K060912 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Tomotherapy Treatment System Fast Optimizer

  Class II

  FDA 510(k) K112776 Active Cleared 22 Dec 2011

• Modification to: Hi-Art System

  Class II

  FDA 510(k) K033347 Active Cleared 12 Nov 2003

• Modification to Hi-Art Treatment System

  Class II

  FDA 510(k) K082005 Active Cleared 25 Aug 2008

• Hi-Art System

  Class II

  FDA 510(k) K042739 Active Cleared 3 Nov 2004

• Tomotherapy Treatment System

  Class II

  FDA 510(k) K112446 Active Cleared 7 Oct 2011