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510(k) K071870

HEXAPOD RT COUCH TOP by Medical Intelligence Medizintechnik GmbH — Product Code JAI

K071870 is an FDA 510(k) premarket notification submitted by Medical Intelligence Medizintechnik GmbH for the device "HEXAPOD RT COUCH TOP". The FDA issued a decision of Substantially Equivalent on July 8, 2007. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Medical Intelligence Medizintechnik GmbH has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2007
Date Received
July 6, 2007
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

  • K143485 — iGuide 2.1 (March 4, 2015)
  • K121530 — BODYFIX SYSTEM (June 20, 2012)
  • K112210 — FRAXION (November 22, 2011)
  • K072898 — HEXAPOD EVO RT COUCH TOP (October 25, 2007)
  • K041448 — HEXAPOD RT COUCHTOP (June 16, 2004)
  • K030439 — HEADFIX (May 8, 2003)
  • K013391 — BODYFIX (January 11, 2002)

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)

FDA data resources