Cleared Traditional

K023073 - SEED LINK

K023073 is an FDA 510(k) clearance for SEED LINK, manufactured by Implant Sciences Corp.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K023073 · Implant Sciences Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
203d
Days
Class 2
Risk

K023073 is an FDA 510(k) clearance for the SEED LINK. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Implant Sciences Corp. (Wakefield, US). The FDA issued a Cleared decision on April 7, 2003 after a review of 203 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 - K023073

510(k) Number K023073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2002
Decision Date April 07, 2003
Days to Decision 203 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
96d slower than avg
Panel avg: 107d · This submission: 203d
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 K023073.
VARISEED 7.1
K030534 · Varian Medical Systems · May 2003
READI-LOAD SYSTEM, MODEL PSS 1820RL
K022389 · Worldwide Medical Technologies, LLC · May 2003
I-125 RAPID STRAND, MODEL 7000
K030594 · Amersham Health · Apr 2003
SEEDLINKS, MODELS 70301, 70302, 70303
K023210 · Sourcetech Medical, LLC · Mar 2003
LAWRENCE CSERION, MODEL CS-1
K030162 · Isoray, Inc. · Mar 2003
ALTON PT STEPPER
K024183 · Alton Design, LLC · Mar 2003
K023073 · SEED LINK
Download PDF FDA Summary Implant Sciences Corp.