510(k) Report

FDA applicant

Ibt SA

Norcross, GA3 decisions2001–20050 recalls

FDA records 3 decisions for Ibt SA (Norcross, GA) from 2001 to 2005: 3 510(k) clearances. All are in product code KXK (Source, Brachytherapy, Radionuclide). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Ibt, 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 Ibt SA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ibt SA since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ibt SA 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 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K011155Interstrand 125 & Interstrand 103, Model Numbers 1251S and 1031SIbt, Inc. · 20013cite it
  • K041702EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.)Ibt SA · 20041cites it
  • K043336Optistrand, Model 1032SIbt SA · 20051cites it

What has FDA decided for it lately?

  • K043336Optistrand, Model 1032SIbt SA · 2005
  • K041702EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.)Ibt SA · 2004
  • K011155Interstrand 125 & Interstrand 103, Model Numbers 1251S and 1031SIbt, Inc. · 2001

All 2 as Ibt SA →The one decision as Ibt, Inc. →