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510(k) K151666

Leksell GammaPlan by Elekta Instrument AB — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2015
Date Received
June 19, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Elekta Instrument AB

  • K190887 — Leksell Vantage Stereotactic System (August 1, 2019)
  • K173789 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (March 30, 2018)
  • K173791 — Leksell GammaPlan (February 9, 2018)
  • K171123 — Leksell Vantage Stereotactic System (September 15, 2017)
  • K160440 — Leksell Gamma Knife Icon (April 20, 2016)
  • K152558 — Leksell Stereotactic System, Injection/ Aspiration Needle Kit (March 2, 2016)
  • K151159 — Leksell Gamma Knife Perfexion (October 29, 2015)
  • K151561 — Leksell Gamma Knife Icon (August 4, 2015)
  • K133565 — LEKSELL GAMMA KNIFE PERFEXION (May 9, 2014)
  • K120811 — LEKSELL GAMMA KNIFE PERFEXION (May 24, 2012)

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