System, Applicator, Radionuclide, Remote Controlled

Q: What is the product code of K170203?

The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.

FDA 510(k) K170203 · Kobold, LLC

Substantially Equivalent

510(k) numberK170203

Submission

Device name: System, Applicator, Radionuclide, Remote Controlled
Applicant: Kobold, LLC
Liberty Lake, WA, US
Received: January 23, 2017
Decision date: June 1, 2017
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JAQ – System, Applicator, Radionuclide, Remote-Controlled
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.5700
Specialty: Radiology

Other 510(k)s with product code JAQ

510(k)	Device	Applicant	Decision
K262383	LumenCare AzureJAQ · Special	Nucletron B.V.	07/24/2026SE
K252717	MAASTRO Rectal Applicator SetJAQ · Traditional	Varian Medical Systems	05/20/2026SE
K251037	Rectal ApplicatorJAQ · Traditional	Nucletron B.V.	12/19/2025SE
K252884	Guided Aarhus Applicator SetJAQ · Traditional	Varian Medical Systems	11/19/2025SE
K250299	CT/ MR Tandem and Ovoid SetJAQ · Traditional	Varian Medical Systems, Inc.	05/09/2025SE
K250289	Intracavitary/Interstitial SystemJAQ · Traditional	Varian Medical Systems	04/25/2025SE
K243939	Titanium Flexible Geometry FSD Applicator Set (GM11013400)JAQ · Traditional	Varian Medical Systems, Inc.	03/03/2025SE
K241764	Mould Probe MR SafeJAQ · Traditional	Varian Medical Systems, Inc.	01/10/2025SE
K242961	Intraluminal Applicator SetJAQ · Traditional	Varian Medical Systems	11/26/2024SE
K243045	BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)JAQ · Special	Braxx Biotech Co., Ltd.	11/19/2024SE

More from Braxx Biotech Co., Ltd.

510(k)	Device	Decision
K160610	Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and…JAQ · Traditional	02/13/2017SE
K142330	Kobold Ring and Tandem Applicator SetJAQ · Traditional	04/09/2015SE

Questions and answers

When was System, Applicator, Radionuclide, Remote Controlled cleared by the FDA?

System, Applicator, Radionuclide, Remote Controlled (K170203) received a 510(k) decision of Substantially Equivalent on June 1, 2017, 129 days after the submission was received.

What is the product code of K170203?

The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.