FDA applicant

Mitsubishi Electronics America, Inc.

Rockville, MD3 decisions1997–19980 recalls

FDA records 3 decisions for Mitsubishi Electronics America, Inc. (Rockville, MD) from 1997 to 1998: 3 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). 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 Mitsubishi Electronics America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mitsubishi Electronics America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Mitsubishi”

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

Mitsubishi Intl. Corp. 5 Mitsubishi Kagaku Iatron 4 Mitsubishi Heavy Industries, Ltd. 3 Mitsubishi Chemical Medience Corporation 3 Mitsubishi Cable America, Inc. 3 Mitsubishi Yuka America, Inc. 2 Mitsubishi Electric Corporation Kyoto Works 1

Mitsubishi Electronics America, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Mitsubishi”