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510(k) K142219

GammaBeam 100 by Best Theratronics Limited — Product Code IWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2014
Date Received
August 12, 2014
Clearance Type
Special
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 Best Theratronics Limited

  • K181737 — Raycell MK1 (January 2, 2019)
  • K161324 — Raycell Mk2 (August 12, 2016)
  • K150191 — GammaBeam 500 (April 17, 2015)

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  • K200050 — Akesis Galaxy RTx (February 4, 2020)
  • K190844 — Akesis Galaxy (September 4, 2019)
  • K180571 — GammaPod (April 4, 2018)
  • K173789 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (March 30, 2018)
  • K173791 — Leksell GammaPlan (February 9, 2018)