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510(k) K180515

GammaTile by Isoray Medical, Inc. — Product Code KXK

K180515 is an FDA 510(k) premarket notification submitted by Isoray Medical, Inc. for the device "GammaTile". The FDA issued a decision of Substantially Equivalent on July 6, 2018. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Isoray Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2018
Date Received
February 27, 2018
Clearance Type
Traditional
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 Isoray Medical, Inc.

  • K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge (December 31, 2020)
  • K111931 — GLIASITE RTS (August 5, 2011)
  • K092458 — PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRAND (August 28, 2009)
  • K092136 — PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 (August 7, 2009)

Other clearances for product code KXK

  • K252296 — OncoPatch (December 5, 2025)
  • 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)
  • K190296 — GammaTile (March 13, 2019)
  • K171487 — Sirius MRI Marker NS (August 25, 2017)

FDA data resources