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510(k) K914808

LEKSELL GAMMAPLAN (LGP) by Elekta Instruments, Inc. — Product Code IWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1992
Date Received
October 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, Radionuclide
Device Class
Class II
Regulation Number
892.5750
Review Panel
RA
Submission Type

Other clearances by Elekta Instruments, Inc.

  • K983678 — ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE (January 15, 1999)
  • 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)

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  • K173791 — Leksell GammaPlan (February 9, 2018)