510(k) Report

FDA applicant

International Brachytherapy S.A.

Norcross, GA3 decisions1998–20040 recalls

FDA records 3 decisions for International Brachytherapy S.A. (Norcross, GA) from 1998 to 2004: 3 510(k) clearances. All are in product code KXK (Source, Brachytherapy, Radionuclide). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “International Brachytherapy, Inc.”.

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 Brachytherapy S.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for International Brachytherapy S.A. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KXKSource, Brachytherapy, Radionuclide3decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K040766Optisource, Model 1032PInternational Brachytherapy S.A. · 20042cite it
  • K973328IntersourceInternational Brachytherapy S.A. · 19982cite it
  • K984235Intersource 125, Model 1251LInternational Brachytherapy, Inc. · 19991cites it

What has FDA decided for it lately?

  • K040766Optisource, Model 1032PInternational Brachytherapy S.A. · 2004
  • K984235Intersource 125, Model 1251LInternational Brachytherapy, Inc. · 1999
  • K973328IntersourceInternational Brachytherapy S.A. · 1998

All 2 as International Brachytherapy S.A. →The one decision as International Brachytherapy, Inc. →