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510(k) K190887

Leksell Vantage Stereotactic System by Elekta Instrument AB — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2019
Date Received
April 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

Other clearances by Elekta Instrument AB

  • 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)
  • K151666 — Leksell GammaPlan (September 3, 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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