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510(k) K190296

GammaTile by Gt Medical Technologies — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2019
Date Received
February 11, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Gt Medical Technologies

  • K221539 — GammaTile (November 9, 2022)
  • K190839 — GammaTile (January 23, 2020)

Other clearances for product code KXK

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  • K242818 — IsoSphere (July 15, 2025)
  • K223465 — RadianceTx Radionuclide Brachytherapy Source (January 11, 2023)
  • K221539 — GammaTile (November 9, 2022)
  • K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge (December 31, 2020)
  • K193602 — LV Liberty Vision Model 1 90Yttrium Brachytherapy Source (May 29, 2020)
  • K190839 — GammaTile (January 23, 2020)
  • K191324 — CivaDerm (September 20, 2019)
  • K180515 — GammaTile (July 6, 2018)
  • K171487 — Sirius MRI Marker NS (August 25, 2017)