Art Brachytherapy Applicator

FDA 510(k) K060299 · Advanced Radiation Therapy, LLC

Substantially Equivalent

510(k) numberK060299

Submission

Device name
Art Brachytherapy Applicator
Applicant
Advanced Radiation Therapy, LLC
Billerica, MA, US
Received
February 6, 2006
Decision date
June 6, 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

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Questions and answers

When was Art Brachytherapy Applicator cleared by the FDA?

Art Brachytherapy Applicator (K060299) received a 510(k) decision of Substantially Equivalent on June 6, 2006, 120 days after the submission was received.

What is the product code of K060299?

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