Cleared Traditional

K003206 - GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K003206 · Proxima Therapeutics, Inc. · Radiology device
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Apr 2001
Decision
194d
Days
Class 2
Risk

K003206 is an FDA 510(k) clearance for the GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Proxima Therapeutics, Inc. (Alpharetta, US). The FDA issued a Cleared decision on April 25, 2001 after a review of 194 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - 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 Proxima Therapeutics, Inc. devices

Submission Details

510(k) Number K003206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2000
Decision Date April 25, 2001
Days to Decision 194 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
87d slower than avg
Panel avg: 107d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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.