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510(k) K062639

MODIFICATION TO HEXAPOD RT COUCH TOP by Medical Intelligence Medizintechnik-GmbH-An Elekta — Product Code JAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2006
Date Received
September 6, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Medical Intelligence Medizintechnik-GmbH-An Elekta

  • K072079 — IGUIDE SYSTEM (August 14, 2007)
  • K062611 — IGUIDE SYSTEM (September 20, 2006)

Other clearances for product code JAI

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  • 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)