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510(k) K060870

AVANZA by Mds Nordion — Product Code JAI

K060870 is an FDA 510(k) premarket notification submitted by Mds Nordion for the device "AVANZA". The FDA issued a decision of Substantially Equivalent on May 15, 2006. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Mds Nordion has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2006
Date Received
March 30, 2006
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 Mds Nordion

  • K053485 — THERATRON EQUINOX, MODELS 80 CM AND 100 CM (March 9, 2006)
  • K051065 — RAYCELL X-RAY BLOOD IRRADIATOR (May 26, 2005)
  • K050963 — GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN (May 20, 2005)
  • K032684 — RAYCELL (September 26, 2003)
  • K020971 — DCM 2.0 (June 6, 2002)
  • K010682 — HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM (June 5, 2001)
  • K011246 — DCM 1.0 (May 23, 2001)
  • K001006 — THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE (April 27, 2000)

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