FDA applicant

Otsuka Electronics

Fort Collins, CO2 decisions1992–19930 recalls

FDA records 2 decisions for Otsuka Electronics (Fort Collins, CO) from 1992 to 1993: 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’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Otsuka Electronics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Otsuka Electronics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Otsuka”

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

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

Otsuka Electronics

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Otsuka”