510(k) Report

FDA applicant

Otsuka Electronics USA, Inc.

Fort Collins, CO2 decisions1994–19940 recalls

FDA records 2 decisions for Otsuka Electronics USA, Inc. (Fort Collins, CO) in 1994: 2 510(k) clearances. 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 Otsuka Electronics USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Otsuka Electronics USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Otsuka Electronics USA, 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

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K942953Oracle Mri Whole Body MR Imaging SystemOtsuka Electronics USA, Inc. · 19941cites it

What has FDA decided for it lately?

  • K942953Oracle Mri Whole Body MR Imaging SystemOtsuka Electronics USA, Inc. · 1994
  • K942776Magnetic Resonance Angiography Capability/OE 1.5 S1Otsuka Electronics USA, Inc. · 1994

All 2 as Otsuka Electronics USA, Inc. →

Other applicant names beginning “Otsuka”

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

Otsuka Pharmaceutical Co., Ltd. 6Otsuka America Pharmaceutical, Inc. 3Otsuka Electronics 2