Cleared Abbreviated

K103319 - I-SEED

K103319 is an FDA 510(k) clearance for I-SEED, manufactured by Theragenics Corp.. The device is a Class 2 Radiology device with product code KXK cleared through the Abbreviated 510(k) pathway after a 52-day FDA review.

K103319 · Theragenics Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
52d
Days
Class 2
Risk

K103319 is an FDA 510(k) clearance for the I-SEED. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Theragenics Corp. (Buford, US). The FDA issued a Cleared decision on January 3, 2011 after a review of 52 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 - K103319

510(k) Number K103319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2010
Decision Date January 03, 2011
Days to Decision 52 days
Submission Type Abbreviated
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
55d faster than avg
Panel avg: 107d · This submission: 52d
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 145
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K103319.
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BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
K103449 · Riverpoint Medical · Feb 2011
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K100847 · Biocompatibles, Inc. · May 2010
RADIONUCLIDE BRACHYTHERAPY SOURCE
K093663 · C.R. Bard, Inc. · Dec 2009
ACU007S
K092522 · Oncology Systems, Inc. · Nov 2009
K103319 · I-SEED
Download PDF FDA Summary Theragenics Corp.