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

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.

Clearance details

Applicant
Eizo Corporation
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hakusan, Ishikawa, JP
Download summary PDFView on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

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

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