510(k) Report

FDA applicant

Hudson Diagnostic Imaging, LLC

Elmwood Park, NJ2 decisions2002–20040 recalls

FDA records 2 decisions for Hudson Diagnostic Imaging, LLC (Elmwood Park, NJ) from 2002 to 2004: 2 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Hudson Diagnostic Imaging, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hudson Diagnostic Imaging, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Hudson”

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