510(k) Report

FDA applicant

Imig-Mri Systems, LLC

Tyngsborough, MA1 decision1996–19960 recalls

FDA records 1 decision for Imig-Mri Systems, LLC (Tyngsborough, MA) in 1996: 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 Imig-Mri Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Imig-Mri Systems, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Imig-Mri Systems, LLC 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?

  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K963953Imig-MriImig-Mri Systems, LLC · 19962cite it

What has FDA decided for it lately?

  • K963953Imig-MriImig-Mri Systems, LLC · 1996

The one decision as Imig-Mri Systems, LLC →