510(k) Report

FDA applicant

Eigen Video

Nevada City, CA4 decisions1985–19940 recalls

FDA records 4 decisions for Eigen Video (Nevada City, CA) from 1985 to 1994: 4 510(k) clearances. Most are in product codes JAA (System, X-Ray, Fluoroscopic, Image-Intensified) and LLZ (System, Image Processing, Radiological). 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 Eigen Video’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eigen Video since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Eigen”

FDA records each applicant name separately; these may or may not be the same firm.