Art Shielded Breast Applicator

FDA 510(k) K062135 · Advanced Radiation Therapy, LLC

Substantially Equivalent

510(k) numberK062135

Submission

Device name
Art Shielded Breast Applicator
Applicant
Advanced Radiation Therapy, LLC
Billerica, MA, US
Received
July 26, 2006
Decision date
November 7, 2006
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)DeviceApplicantDecision
K262383LumenCare AzureJAQ · Special Nucletron B.V.07/24/2026SE
K252717MAASTRO Rectal Applicator SetJAQ · Traditional Varian Medical Systems05/20/2026SE
K251037Rectal ApplicatorJAQ · Traditional Nucletron B.V.12/19/2025SE
K252884Guided Aarhus Applicator SetJAQ · Traditional Varian Medical Systems11/19/2025SE
K250299CT/ MR Tandem and Ovoid SetJAQ · Traditional Varian Medical Systems, Inc.05/09/2025SE
K250289Intracavitary/Interstitial SystemJAQ · Traditional Varian Medical Systems04/25/2025SE
K243939Titanium Flexible Geometry FSD Applicator Set (GM11013400)JAQ · Traditional Varian Medical Systems, Inc.03/03/2025SE
K241764Mould Probe MR SafeJAQ · Traditional Varian Medical Systems, Inc.01/10/2025SE
K242961Intraluminal Applicator SetJAQ · Traditional Varian Medical Systems11/26/2024SE
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)DeviceDecision
K060299Art Brachytherapy ApplicatorJAQ · Traditional 06/06/2006SE

Questions and answers

When was Art Shielded Breast Applicator cleared by the FDA?

Art Shielded Breast Applicator (K062135) received a 510(k) decision of Substantially Equivalent on November 7, 2006, 104 days after the submission was received.

What is the product code of K062135?

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