Cleared Abbreviated

K082530 - APPLICATORS FOR AFTERLOADING BRACHYTHERAPY

K082530 is an FDA 510(k) clearance for APPLICATORS FOR AFTERLOADING BRACHYTHERAPY, manufactured by Isodose Control B.V.. The device is a Class 2 Radiology device with product code JAQ cleared through the Abbreviated 510(k) pathway after a 58-day FDA review.

K082530 · Isodose Control B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
58d
Days
Class 2
Risk

K082530 is an FDA 510(k) clearance for the APPLICATORS FOR AFTERLOADING BRACHYTHERAPY. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Isodose Control B.V. (Ede, NL). The FDA issued a Cleared decision on October 30, 2008 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Isodose Control B.V. devices

FDA 510(k) Submission Details - K082530

510(k) Number K082530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2008
Decision Date October 30, 2008
Days to Decision 58 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Standards-based clearance path.

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 135
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