510(k) Report

FDA applicant

Nishimoto Sangyo Co., Ltd.

San Leandro, CA2 decisions1999–20010 recalls

FDA records 2 decisions for Nishimoto Sangyo Co., Ltd. (San Leandro, CA) from 1999 to 2001: 2 510(k) clearances. Most are in product codes LMC (Camera, Multi Format, Radiological) and LMA (Digitizer, Image, Radiological). 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 Nishimoto Sangyo Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nishimoto Sangyo Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Nishimoto Sangyo 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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