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510(k) K981992

ELECTRON WEDGE MODEL MT-EW-1000 by Med-Tec,Inc. — Product Code IXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1998
Date Received
June 8, 1998
Clearance Type
Traditional
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 Med-Tec,Inc.

  • K034054 — PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 (February 20, 2004)
  • K031866 — MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC (August 14, 2003)
  • K021360 — SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 (June 10, 2003)
  • K023293 — MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 (December 23, 2002)
  • K013875 — MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE (September 27, 2002)
  • K001052 — MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX (August 30, 2000)
  • K982624 — MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 (October 26, 1998)

Other clearances for product code IXI

  • K222639 — VHA Radiotherapy Bolus (November 4, 2022)
  • K214093 — VSP Bolus (March 30, 2022)
  • K132236 — .DECIMAL PROTON APERTURE (October 16, 2013)
  • 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)