FDA applicant

Toshiba Medical Systems

Tustin, CA54 decisions1977–19960 recalls

FDA records 54 decisions for Toshiba Medical Systems (Tustin, CA) from 1977 to 1996: 54 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 1 predicate, 0 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 Toshiba Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Toshiba Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Toshiba”

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

Toshiba America Medical Systems, In.C 146 Toshiba America Mri, Inc. 68 Toshiba Medical Systems Corporation, Japan 9 Toshiba Medical Systems Coporation, Japan 5 Toshiba Medical Systems Coroporation 2 Toshiba America Electronic Components, Inc. 1 Toshiba Glass Co., Ltd. 1

Toshiba Medical Systems

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Toshiba”