510(k) Report

FDA applicant

Vanderbilt University

Nashville, TN1 decision2004–20040 recalls

FDA records 1 decision for Vanderbilt University (Nashville, TN) in 2004: 1 510(k) clearance. All are in product code IYX (Camera, Scintillation (Gamma)). 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 Vanderbilt University’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vanderbilt University since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vanderbilt University 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?

  • IYXCamera, Scintillation (Gamma)1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K033960Olinda/ExmVanderbilt University · 20043cite it

What has FDA decided for it lately?

  • K033960Olinda/ExmVanderbilt University · 2004

The one decision as Vanderbilt University →