510(k) Report

FDA applicant

Rogan Imaging Corp.

Waukesha, WI1 decision1995–19950 recalls

FDA records 1 decision for Rogan Imaging Corp. (Waukesha, WI) in 1995: 1 510(k) clearance. All are in product code LMD (System, Digital Image Communications…). 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 Rogan Imaging Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rogan Imaging Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rogan Imaging Corp. 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?

  • LMDSystem, Digital Image Communications, Radiological1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K950343Hyperpacs Pacs and Telerafiology SystemRogan Imaging Corp. · 19951cites it

What has FDA decided for it lately?

  • K950343Hyperpacs Pacs and Telerafiology SystemRogan Imaging Corp. · 1995

The one decision as Rogan Imaging Corp. →