I-Plant, Model 3500

Q: What is the product code of K994317?

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

FDA 510(k) K994317 · Implant Sciences Corp.

Substantially Equivalent

510(k) numberK994317

Submission

Device name: I-Plant, Model 3500
Applicant: Implant Sciences Corp.
Wakefield, MA, US
Received: December 22, 1999
Decision date: March 21, 2000
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

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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
K070468	Implant Sciences Corp. Model HDR 4454KXK · Special	03/23/2007SE
K042864	Implant Sciences Corp, Model HDR-4140KXK · Traditional	01/06/2005SE
K023073	Seed LinkKXK · Traditional	04/07/2003SE
K023242	I-Plant Model 3500 (125IODINE Brachytherapy Seeds)-SterileKXK · Special	12/04/2002SE
K990193	Iodine Brachytherapy Seeds, Model 3000KXK · Traditional	05/20/1999SE

Questions and answers

When was I-Plant, Model 3500 cleared by the FDA?

I-Plant, Model 3500 (K994317) received a 510(k) decision of Substantially Equivalent on March 21, 2000, 90 days after the submission was received.

What is the product code of K994317?

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