510(k) Report

FDA applicant

Innovative Magnetic Resonance Imaging Systems, Inc.

Rockville, MD2 decisions2000–20050 recalls

FDA records 2 decisions for Innovative Magnetic Resonance Imaging Systems, Inc. (Rockville, MD) from 2000 to 2005: 2 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 3 predicates, 1 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 Innovative Magnetic Resonance Imaging Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Innovative Magnetic Resonance Imaging Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Innovative Magnetic Resonance Imaging Systems, Inc. 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 Imaging2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K002964Neuro IIInnovative Magnetic Resonance Imaging Systems, Inc. · 20001cites it

What has FDA decided for it lately?

  • K050132Neuro II-SInnovative Magnetic Resonance Imaging Systems, Inc. · 2005
  • K002964Neuro IIInnovative Magnetic Resonance Imaging Systems, Inc. · 2000

All 2 as Innovative Magnetic Resonance Imaging Systems, Inc. →