510(k) Report

FDA applicant

International Isotopes, Inc.

Denton, TX2 decisions1998–19990 recalls

FDA records 2 decisions for International Isotopes, Inc. (Denton, TX) from 1998 to 1999: 2 510(k) clearances. Most are in product codes IWG (Seed, Isotope, Gold, Titanium, Platinum) and KXK (Source, Brachytherapy, Radionuclide). Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided International Isotopes, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for International Isotopes, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — International Isotopes, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like International Isotopes, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IWGSeed, Isotope, Gold, Titanium, Platinum1decision
  • KXKSource, Brachytherapy, Radionuclide1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K982421Imagyn 125 I Seed, Model IS 125International Isotopes, Inc. · 19982cite it

What has FDA decided for it lately?

  • K992963I3RAD 125 I Brachytherapy Seed, Model I125-0401International Isotopes, Inc. · 1999
  • K982421Imagyn 125 I Seed, Model IS 125International Isotopes, Inc. · 1998

All 2 as International Isotopes, Inc. →