Home / 510(k) Clearances / K202267

510(k) K202267

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles by Isoray Medical, Inc. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2020
Date Received
August 11, 2020
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.

  • K180515 — GammaTile (July 6, 2018)
  • 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)
  • 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)
  • K180515 — GammaTile (July 6, 2018)
  • K171487 — Sirius MRI Marker NS (August 25, 2017)