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510(k) K041448

HEXAPOD RT COUCHTOP by Medical Intelligence Medizintechnik GmbH — Product Code JAI

K041448 is an FDA 510(k) premarket notification submitted by Medical Intelligence Medizintechnik GmbH for the device "HEXAPOD RT COUCHTOP". The FDA issued a decision of Substantially Equivalent on June 16, 2004. 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
June 16, 2004
Date Received
June 1, 2004
Clearance Type
Traditional
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)
  • K071870 — HEXAPOD RT COUCH TOP (July 8, 2007)
  • 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