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510(k) K030609

MODULEAF by Mrc Systems GmbH — Product Code IXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2003
Date Received
February 26, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Beam-Shaping, Radiation Therapy
Device Class
Class II
Regulation Number
892.5710
Review Panel
RA
Submission Type

Other clearances by Mrc Systems GmbH

  • K022307 — KONRAD, MODEL V.2.0 (October 8, 2002)
  • K011816 — MINI MULTILEAF COLLIMATOR, MODEL KMI (September 7, 2001)

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  • K131150 — CURA COMPENSATOR (July 30, 2013)
  • K123893 — CURA COLLIMATOR (March 4, 2013)
  • K123015 — .DECIMAL PHOTON BLOCK (November 21, 2012)
  • K111676 — APEX (September 30, 2011)
  • K111759 — .DECIMAL ELECTRON APERTURE (September 9, 2011)
  • K091403 — MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY (July 29, 2009)
  • K091911 — BOLUS COMPENSATOR (July 21, 2009)