Cleared Traditional

K062135 - ART SHIELDED BREAST APPLICATOR

K062135 is an FDA 510(k) clearance for ART SHIELDED BREAST APPLICATOR, manufactured by Advanced Radiation Therapy, LLC. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K062135 · Advanced Radiation Therapy, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
104d
Days
Class 2
Risk

K062135 is an FDA 510(k) clearance for the ART SHIELDED BREAST APPLICATOR. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Advanced Radiation Therapy, LLC (Billerica, US). The FDA issued a Cleared decision on November 7, 2006 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Radiation Therapy, LLC devices

FDA 510(k) Submission Details - K062135

510(k) Number K062135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2006
Decision Date November 07, 2006
Days to Decision 104 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAQ Device Classification - Class 2, Special Controls

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAQ System, Applicator, Radionuclide, Remote-controlled

All 137
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K062135.
VARIAN ESOPHAGUS BOUGIE APPLICATOR
K063815 · Varian Medical Systems · Mar 2007
HDR CT COMPATIBLE SPLIT RING APPLICATOR
K063382 · Mick Radio-Nuclear Instruments, Inc. · Dec 2006
CT COMPATIBLE F/S/D APPLICATORS
K063381 · Mick Radio-Nuclear Instruments, Inc. · Dec 2006
MICROSELECTRON V3, MODEL 106.990
K061354 · Nucletron Corporation · Aug 2006
VARISOURCE 200 HDR AFTERLOADER
K061582 · Varian Medical Systems, Inc. · Jul 2006
PROGUIDE NEEDLE SET
K060349 · Nucletron Corporation · Mar 2006