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510(k) K983678

ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE by Elekta Instruments, Inc. — Product Code JAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1999
Date Received
October 20, 1998
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 Elekta Instruments, Inc.

  • K955064 — SPETZLER TI 100 ANEURYSM CLIP (October 17, 1996)
  • K941823 — LEKSELL NEURO GENERATOR AND ACCESSORIES (March 22, 1996)
  • K946165 — CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM (May 23, 1995)
  • K943468 — LEKSELL SURGIPLAN (January 20, 1995)
  • K932261 — ES-100 ACCESSORIES (January 7, 1994)
  • K925360 — ES-100 POWER SYSTEM, ES-100 SERIES (September 7, 1993)
  • K914808 — LEKSELL GAMMAPLAN (LGP) (January 23, 1992)

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)