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510(k) K034054

PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 by Med-Tec,Inc. — Product Code JAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2004
Date Received
December 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Couch, Radiation Therapy, Powered
Device Class
Class II
Regulation Number
892.5770
Review Panel
RA
Submission Type

Other clearances by Med-Tec,Inc.

  • 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)
  • K981992 — ELECTRON WEDGE MODEL MT-EW-1000 (December 15, 1998)
  • K982624 — MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 (October 26, 1998)

Other clearances for product code JAI

  • K231612 — Eve Patient Positioner System (May 7, 2024)
  • K182683 — Z-Robot Patient Positioning System (June 27, 2019)
  • K170502 — Patient Positioning System (April 13, 2017)
  • K160518 — LEONI ORION System (July 14, 2016)
  • K132084 — PROTURA COUCH SOFTWARE (September 26, 2013)
  • K122413 — PATIENT POSITIONING SYSTEM (September 13, 2012)
  • K122201 — PROTURA COUCH SOFTWARE (August 30, 2012)
  • K120520 — EXACTRAC ROBOTICS NOVALIS ROBOTICS (June 29, 2012)
  • K120916 — QFIX RADIOTHERAPY CHAIR (June 20, 2012)
  • K072898 — HEXAPOD EVO RT COUCH TOP (October 25, 2007)