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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K013112
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Focal Sim radiation therapy treatment planning system 2 03/04/2015 Elekta, Inc.
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and vie... 2 09/03/2014 Elekta, Inc.
Focal SIM Planning of radiation therapy 2 07/12/2012 Elekta, Inc.
Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiatio... 2 06/20/2011 Computerized Medical Systems Inc
Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above. Product Usage: for ... 2 06/20/2011 Computerized Medical Systems Inc
Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above for use in radiation ... 2 06/20/2011 Computerized Medical Systems Inc
Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00. Product Usage: ... 2 06/20/2011 Computerized Medical Systems Inc
Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02. For use in radia... 2 06/15/2011 Computerized Medical Systems Inc
Focal Radiation Treatment Planning System, Focal Release 4.34.00 through 4.50.00. For use in rad... 2 06/14/2011 Computerized Medical Systems Inc
Focal Radiation Treatment Planning Workstation. Focal Release 4.51.00 and above. Allows users to ac... 2 06/14/2011 Computerized Medical Systems Inc
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