Cleared Special

K982421 - IMAGYN 125 I SEED, MODEL IS 125

K982421 is an FDA 510(k) clearance for IMAGYN 125 I SEED, manufactured by International Isotopes, Inc.. The device is a Class 2 Radiology device with product code IWG cleared through the Special 510(k) pathway after a 18-day FDA review.

K982421 · International Isotopes, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
18d
Days
Class 2
Risk

K982421 is an FDA 510(k) clearance for the IMAGYN 125 I SEED, MODEL IS 125. Classified as Seed, Isotope, Gold, Titanium, Platinum (product code IWG), Class II - Special Controls.

Submitted by International Isotopes, Inc. (Denton, US). The FDA issued a Cleared decision on July 31, 1998 after a review of 18 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 International Isotopes, Inc. devices

FDA 510(k) Submission Details - K982421

510(k) Number K982421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1998
Decision Date July 31, 1998
Days to Decision 18 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
89d faster than avg
Panel avg: 107d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

IWG Device Classification - Class 2, Special Controls

Product Code IWG Seed, Isotope, Gold, Titanium, Platinum
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.