510(k) Report

FDA applicant

Machnet BV

Deer Field, IL3 decisions2001–20020 recalls

FDA records 3 decisions for Machnet BV (Deer Field, IL) from 2001 to 2002: 3 510(k) clearances. Most are in product codes MOS (Coil, Magnetic Resonance, Specialty) and LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 5 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 Machnet BV’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Machnet BV since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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