510(k) Report

FDA applicant

Totoku Electric Co., Ltd.

Ueda, JP40 decisions2001–20110 recalls

FDA records 40 decisions for Totoku Electric Co., Ltd. (Ueda, JP) from 2001 to 2011: 40 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 40 predicates, 36 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 Totoku Electric Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

5in 2011

2007: 32008: 62010: 22011: 5
2007high 6 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Totoku Electric Co., Ltd.’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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