Cleared Abbreviated

K011119 - BRACHYSEED PD-103 MODELS #PD1

K011119 is an FDA 510(k) clearance for BRACHYSEED PD-103 MODELS #PD1, manufactured by Draximage, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Abbreviated 510(k) pathway after a 74-day FDA review.

K011119 · Draximage, Inc. · Radiology device
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Jun 2001
Decision
74d
Days
Class 2
Risk

K011119 is an FDA 510(k) clearance for the BRACHYSEED PD-103 MODELS #PD1. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Draximage, Inc. (Kirkland, Qc, CA). The FDA issued a Cleared decision on June 25, 2001 after a review of 74 days - a notably fast clearance 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 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.

FDA 510(k) Submission Details - K011119

510(k) Number K011119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2001
Decision Date June 25, 2001
Days to Decision 74 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 107d · This submission: 74d
Pathway characteristics
Standards-based clearance path.

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 K011119.
MBI PD-103 SL
K011427 · Mills Biopharmaceuticals, Inc. · Aug 2001
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
K011155 · Ibt, Inc. · Jul 2001
ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
K011205 · Isoaid · Jul 2001
THERASEED(R) PALLADIUM-103 IMPLANT
K010283 · Theragenics Corp. · Apr 2001
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
K003206 · Proxima Therapeutics, Inc. · Apr 2001
ECHOSEED/IODINE-125 SEEDS, MODEL 6733
K010821 · Medi-Physics Inc. Dba Nycomed Amersham Imaging · Apr 2001
K011119 · BRACHYSEED PD-103 MODELS #PD1
Download PDF Draximage, Inc.