6MP COLOR LCD MONITOR, RADIFORCE RX650— 510(k) K134002

Name: FDA 510(k) clearance K134002
Creator: U.S. Food and Drug Administration
Published: 2014-01-31

Substantially Equivalent

Eizo Corporation

FDA 510(k) clearance K134002 for 6MP COLOR LCD MONITOR, RADIFORCE RX650, Substantially Equivalent on 2014-01-31. Applicant: Eizo Corporation. Device class: 2.

Clearance details

Applicant: Eizo Corporation
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2013-12-27
Decision date: 2014-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hakusan, Ishikawa, JP

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K134002

K-number listed on FDA's recall record

Z-2088-2015 — RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.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 K134002.

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