Raystation

• • Terminated Z-1679-2015 FDA Class II ·initiated 8 May 2015

  RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.

• • Terminated Z-1481-2014 FDA Class II ·initiated 14 Feb 2014

  RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.

• • Terminated Z-1307-2014 FDA Class II ·initiated 6 Feb 2014

  Potential for dose errors due to software program errors.

• • Terminated Z-0281-2014 FDA Class II ·initiated 23 Oct 2013

  Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.

• • Terminated Z-1419-2013 FDA Class II ·initiated 15 Feb 2013

  Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.

• • Terminated Z-2324-2012 FDA Class II ·initiated 9 May 2012

  The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. The dose calculation is not correctly normalized in the unusual case of preventing the optimizatio

1. 6 Apr 2012 Cleared FDA 510(k) K120387
2. 9 May 2012 Recall initiated FDA recalls Z-2324-2012
3. 15 Feb 2013 Recall initiated FDA recalls Z-1419-2013
4. 23 Oct 2013 Recall initiated FDA recalls Z-0281-2014
5. 6 Feb 2014 Recall initiated FDA recalls Z-1307-2014
6. 14 Feb 2014 Recall initiated FDA recalls Z-1481-2014
7. 8 May 2015 Recall initiated FDA recalls Z-1679-2015

510(k) Number

K120387 ↗

FDA product code

MUJ

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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• PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM, MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1 by Nucletron Corp.
• ITP, MODEL 1.0 by Nucletron Corp.

• Raystation Version 1.0

  Class II

  FDA 510(k) K100552 Active Cleared 12 Mar 2010

• Raystation

  Class II

  FDA 510(k) K130617 Active Cleared 10 May 2013

• Rayautoplan 1.0

  Class II

  FDA 510(k) K083264 Active Cleared 22 Jan 2009

• Raydose

  Class II

  FDA 510(k) K082221 Active Cleared 22 Oct 2008

See all devices from Raysearch Laboratories AB →