North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-A

Q: What is the product code of K972271?

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

FDA 510(k) K972271 · Ml Strategies, Inc.

Substantially Equivalent

510(k) numberK972271

Submission

Device name: North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-A
Applicant: Ml Strategies, Inc.
Boston, MA, US
Received: June 18, 1997
Decision date: October 28, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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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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
K983401	Framewave WebLLZ · Traditional	12/15/1998SE
K973363	North American SCIENTIFIC(NASI)PD-103 Radionuclide Brachytherapy Source-Model MED3633IWI · Traditional	07/02/1998SE
K950354	Human Chorionic Gonadotropin (HCG) Test System for the Early Detection of PregnancyLCX · Traditional	07/19/1995SE

Questions and answers

When was North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-A cleared by the FDA?

North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-A (K972271) received a 510(k) decision of Substantially Equivalent on October 28, 1997, 132 days after the submission was received.

What is the product code of K972271?

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