510(k) Report

FDA applicant

Magnevu

Carlsbad, CA1 decision1998–19980 recalls

FDA records 1 decision for Magnevu (Carlsbad, CA) in 1998: 1 510(k) clearance. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). 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 Magnevu’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Magnevu since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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