Cleared Traditional

K142668 - Lesion-Loc Iodine I-125 Seed/Needle

K142668 is an FDA 510(k) clearance for Lesion-Loc Iodine I-125 Seed/Needle, manufactured by Intramedical Imaging, LLC. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K142668 · Intramedical Imaging, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
63d
Days
Class 2
Risk

K142668 is an FDA 510(k) clearance for the Lesion-Loc Iodine I-125 Seed/Needle. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Intramedical Imaging, LLC (Hawthorne, US). The FDA issued a Cleared decision on November 21, 2014 after a review of 63 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K142668

510(k) Number K142668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2014
Decision Date November 21, 2014
Days to Decision 63 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
44d faster than avg
Panel avg: 107d · This submission: 63d
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 140
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K142668.
VariSeed 9.0
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K142701 · Salutaris Medical Devices, Inc. · Dec 2014
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ANT MODEL 1
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CIVA SHEET PD-103
K140490 · Civatech Oncology, Inc. · Aug 2014
ISOSEED
K140849 · Eckert & Ziegler Bebig GmbH · Jul 2014