510(k) Report

FDA applicant

Eizo Nanao Corporation

Ishikawa-Ken, JP34 decisions2002–20131 recall

FDA records 34 decisions for Eizo Nanao Corporation (Ishikawa-Ken, JP) from 2002 to 2013: 34 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 27 predicates, 25 of them its own earlier devices. 1 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 Eizo Nanao Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2007: 32008: 32009: 22010: 12011: 32012: 62013: 2
2007high 6 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Eizo”

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