Raystation Version 1.0

• • 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-1317-2012 FDA Unclassified (pre-2012) ·initiated 6 Dec 2011

  An issue was found with the dose calculation in the RayStation 2.0, that could result in a potential overestimation of the dose. This could lead to the potential under-dosage of a patient.

• • Terminated Z-0359-2012 FDA Unclassified (pre-2012) ·initiated 19 Oct 2011

  The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual. The symptoms involve the Pixel Spacing and Image Position attributes in the RT images being incorrect, thus enabling the user to make measurements that are erroneous and possibly misalign the patient.

1. 12 Mar 2010 Cleared FDA 510(k) K100552
2. 19 Oct 2011 Recall initiated FDA recalls Z-0359-2012
3. 6 Dec 2011 Recall initiated FDA recalls Z-1317-2012
4. 6 Feb 2014 Recall initiated FDA recalls Z-1307-2014
5. 14 Feb 2014 Recall initiated FDA recalls Z-1481-2014

510(k) Number

K100552 ↗

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

  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

• Ray Station

  Class II

  FDA 510(k) K140187 Active Cleared 15 May 2014

See all devices from Raysearch Laboratories AB →