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-1806-2014 FDA Class II ·initiated 25 Apr 2014

  This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.

• • 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-1308-2014 FDA Class II ·initiated 6 Feb 2014

  RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.

• • 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.

1. 10 May 2013 Cleared FDA 510(k) K130617
2. 23 Oct 2013 Recall initiated FDA recalls Z-0281-2014
3. 6 Feb 2014 Recall initiated FDA recalls Z-1307-2014
4. 6 Feb 2014 Recall initiated FDA recalls Z-1308-2014
5. 14 Feb 2014 Recall initiated FDA recalls Z-1481-2014
6. 25 Apr 2014 Recall initiated FDA recalls Z-1806-2014
7. 8 May 2015 Recall initiated FDA recalls Z-1679-2015

510(k) Number

K130617 ↗

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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• RayStation 9B SP1 by RaySearch Laboratories AB (PUBL)
• VITESSE 3.0 by Varian Medical Systems, Oncology Systems

• Raystation Version 1.0

  Class II

  FDA 510(k) K100552 Active Cleared 12 Mar 2010

• Raystation

  Class II

  FDA 510(k) K120387 Active Cleared 6 Apr 2012

• 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 →