Cleared Traditional

K990193 - IODINE BRACHYTHERAPY SEEDS, MODEL 3000

K990193 is an FDA 510(k) clearance for IODINE BRACHYTHERAPY SEEDS, 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 119-day FDA review.

K990193 · Implant Sciences Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
119d
Days
Class 2
Risk

K990193 is an FDA 510(k) clearance for the IODINE BRACHYTHERAPY SEEDS, MODEL 3000. 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 May 20, 1999 after a review of 119 days - within the typical 510(k) review window.

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.

View all Implant Sciences Corp. devices

FDA 510(k) Submission Details - K990193

510(k) Number K990193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1999
Decision Date May 20, 1999
Days to Decision 119 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
12d slower than avg
Panel avg: 107d · This submission: 119d
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 47
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K990193.
INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
K992262 · Indigo Medical, Inc. · Oct 1999
ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
K991526 · Imagyn Medical Technologies, Inc. · Jun 1999
INTERSOURCE 125, MODEL 1251L
K984235 · International Brachytherapy, Inc. · Jun 1999
UROMED BRACHYTHERAPHY IODINE-125 SOURCES
K982226 · Uromed Corp. · May 1999
`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH
K984446 · Urocor, Inc. · Apr 1999
INTERSOURCE
K973328 · International Brachytherapy S.A. · Dec 1998