510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982421Substantially Equivalent

Imagyn 125 I Seed, Model Is 125

International Isotopes, Inc., Denton TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K982421 is the FDA 510(k) clearance record for IMAGYN 125 I SEED, MODEL IS 125, a class II device, cleared for International Isotopes, Inc. on under FDA product code IWG (Seed, Isotope, Gold, Titanium, Platinum). FDA records list 2 510(k) clearances for International Isotopes, Inc., from to . As of , FDA records show no recalls naming K982421.

Clearance record

Decision date
Received
(18 days to decision)
Product code
IWG Seed, Isotope, Gold, Titanium, Platinum
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Applicant
International Isotopes, Inc. 3100 Jim Christal Rd., Denton TX
510(k) summary
Summary
Third party review
No

Clearances, product code IWG

Trailing 12 months

FDA records hold no clearances under product code IWG in the trailing twelve months.

FDA records show no clearances under product code IWG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260