510(k) Report

FDA applicant

Toshiba Medical Systems Coporation, Japan

Tustin, CA5 decisions2011–20124 recalls

FDA records 5 decisions for Toshiba Medical Systems Coporation, Japan (Tustin, CA) from 2011 to 2012: 5 510(k) clearances. Most are in product codes MOS (Coil, Magnetic Resonance, Specialty) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 5 predicates, 1 of them its own earlier devices. 4 recalls are 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 Coporation, Japan’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2011: 32012: 2
2011high 3 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2015

2013: 22014: 12015: 1
2011high 2 (2013) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Toshiba Medical Systems Coporation, Japan by year, 2011–2026Sources: 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.