Cleared Special

K991526 - ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501

K991526 is an FDA 510(k) clearance for ISOSTAR I-125 INTERSTITIAL SEED, manufactured by Imagyn Medical Technologies, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Special 510(k) pathway after a 45-day FDA review.

K991526 · Imagyn Medical Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
45d
Days
Class 2
Risk

K991526 is an FDA 510(k) clearance for the ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Imagyn Medical Technologies, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on June 17, 1999 after a review of 45 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Imagyn Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K991526

510(k) Number K991526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1999
Decision Date June 17, 1999
Days to Decision 45 days
Submission Type Special
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
62d faster than avg
Panel avg: 107d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

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 103
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K991526.
125 IMPLANT SEEDS, MODEL STM1251
K991280 · Sourcetech Medical, LLC · Oct 1999
INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
K992262 · Indigo Medical, Inc. · Oct 1999
I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401
K992963 · International Isotopes, Inc. · Sep 1999
INTERSOURCE 125, MODEL 1251L
K984235 · International Brachytherapy, Inc. · Jun 1999
IODINE BRACHYTHERAPY SEEDS, MODEL 3000
K990193 · Implant Sciences Corp. · May 1999
UROMED BRACHYTHERAPHY IODINE-125 SOURCES
K982226 · Uromed Corp. · May 1999