RadiForce RX360, RX360-AR— 510(k) K182591

Substantially Equivalent

Eizo Corporation

FDA 510(k) clearance K182591 for RadiForce RX360, RX360-AR, Substantially Equivalent on 2018-10-18. 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: 2018-09-20
Decision date: 2018-10-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hakusan, JP

Download summary PDF View on FDA.gov ↗

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Recalls naming K182591

K-number listed on FDA's recall record

Z-2294-2020 — RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.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 K182591.

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