RadiForce GX560, GX560-AR— 510(k) K181609

Substantially Equivalent

Eizo Corporation

FDA 510(k) clearance K181609 for RadiForce GX560, GX560-AR, Substantially Equivalent on 2018-08-24. Applicant: Eizo Corporation. Device class: 2.

Clearance details

Applicant: Eizo Corporation
Product code: Code PGY
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2018-06-19
Decision date: 2018-08-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hakusan, JP

Download summary PDF View on FDA.gov ↗

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Recalls naming K181609

K-number listed on FDA's recall record

Z-2293-2020 — RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.Class II·Ongoing·Eizo Corporation·20190730

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181609.

Data sourced from openFDA. This site is unofficial and independent of the FDA.