Cesitrx, (Liquid CESIUM-131 Solution) for Use with Gliasite RTS

Q: What is the product code of K132996?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.

FDA 510(k) K132996 · Isoray, Inc.

Substantially Equivalent

510(k) numberK132996

Submission

Device name: Cesitrx, (Liquid CESIUM-131 Solution) for Use with Gliasite RTS
Applicant: Isoray, Inc.
Richland, WA, US
Received: September 24, 2013
Decision date: December 17, 2013
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KXK – Source, Brachytherapy, Radionuclide
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.5730
Specialty: Radiology
Implant: Yes

Other 510(k)s with product code KXK

510(k)	Device	Applicant	Decision
K252296	OncoPatchKXK · Traditional	Oncopatch, Inc.	12/05/2025SE
K242818	IsoSphereKXK · Traditional	Isoaid, LLC	07/15/2025SE
K223465	RadianceTx Radionuclide Brachytherapy SourceKXK · Traditional	Radiance Therapeutics, Inc.	01/11/2023SE
K221539	GammaTileKXK · Traditional	Gt Medical Technologies	11/09/2022SE
K202267	Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesKXK · Traditional	Isoray Medical, Inc.	12/31/2020SE
K193602	LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceKXK · Special	Lv Liberty Vision Corporation	05/29/2020SE
K190839	GammaTileKXK · Traditional	Gt Medical Technologies	01/23/2020SE
K191324	CivaDermKXK · Traditional	Civatech Oncology, Inc.	09/20/2019SE
K190296	GammaTileKXK · Special	Gt Medical Technologies	03/13/2019SE
K180515	GammaTileKXK · Traditional	Isoray Medical, Inc.	07/06/2018SE

More from Isoray Medical, Inc.

510(k)	Device	Decision
K062384	CESIUM-131 Strand, Strand Preload, Preload, S-CartridgeKXK · Special	11/09/2006SE
K030162	Lawrence Cserion, Model CS-1KXK · Abbreviated	03/28/2003SE

Questions and answers

When was Cesitrx, (Liquid CESIUM-131 Solution) for Use with Gliasite RTS cleared by the FDA?

Cesitrx, (Liquid CESIUM-131 Solution) for Use with Gliasite RTS (K132996) received a 510(k) decision of Substantially Equivalent on December 17, 2013, 84 days after the submission was received.

What is the product code of K132996?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.