FDA applicant

I.Z.I. Corp.

Owings Mills, MD7 decisions1992–200226 recalls

FDA records 7 decisions for I.Z.I. Corp. (Owings Mills, MD) from 1992 to 2002: 7 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and KPQ (System, Simulation, Radiation Therapy). 26 recalls are 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 I.Z.I. Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for I.Z.I. Corp. since 2007.

Recalls per year

1in 2022

2007high 25 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

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I.Z.I. Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?