8MP COLOR LCD MONITOR, RADIFORCE RX850— 510(k) K140702

Name: FDA 510(k) clearance K140702
Creator: U.S. Food and Drug Administration
Published: 2014-04-04

Substantially Equivalent

Eizo Corporation

FDA 510(k) clearance K140702 for 8MP COLOR LCD MONITOR, RADIFORCE RX850, Substantially Equivalent on 2014-04-04. 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: 2014-03-20
Decision date: 2014-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hakusan, Ishikawa, JP

Download summary PDF View on FDA.gov ↗

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Recalls naming K140702

K-number listed on FDA's recall record

Z-2089-2015 — RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing digital images those of digital mammography for review and analysis by trained medical practitioners.Class II·Terminated·Eizo Corporation·20150707

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140702.

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