Cleared Traditional

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

K003206 is an FDA 510(k) clearance for GLIASITE RADIATION THERAPY SYSTEM (RTS), manufactured by Proxima Therapeutics, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K003206 · Proxima Therapeutics, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K003206

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
Combination Product No
PCCP Authorized No
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.

KXK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KXK Source, Brachytherapy, Radionuclide

All 150
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K003206.
ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
K011205 · Isoaid · Jul 2001
BRACHYSEED PD-103 MODELS #PD1
K011119 · Draximage, Inc. · Jun 2001
THERASEED(R) PALLADIUM-103 IMPLANT
K010283 · Theragenics Corp. · Apr 2001
ECHOSEED/IODINE-125 SEEDS, MODEL 6733
K010821 · Medi-Physics Inc. Dba Nycomed Amersham Imaging · Apr 2001
SELECT SEED I-125
K002429 · Nucletron Corp. · Feb 2001
RADIOMED SOURCE
K001070 · Radiomed Corp. · Oct 2000
K003206 · GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
Download PDF FDA Summary Proxima Therapeutics,…