CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS— 510(k) K132996

Name: FDA 510(k) clearance K132996
Creator: U.S. Food and Drug Administration
Published: 2013-12-17

Substantially Equivalent

Isoray, Inc.

FDA 510(k) clearance K132996 for CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS, Substantially Equivalent on 2013-12-17. Applicant: Isoray, Inc.. Device class: 2.

Clearance details

Applicant: Isoray, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2013-09-24
Decision date: 2013-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richland, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXK

view all

K252296 — OncoPatch2025-12-05
K242818 — IsoSphere2025-07-15
K223465 — RadianceTx Radionuclide Brachytherapy Source2023-01-11
K221539 — GammaTile2022-11-09
K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles2020-12-31

More clearances from Isoray, Inc.

view all

K062384 — CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE2006-11-09
K030162 — LAWRENCE CSERION, MODEL CS-12003-03-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.