PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR— 510(k) K060136

Substantially Equivalent

Planar Systems, Inc.

FDA 510(k) clearance K060136 for PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR, Substantially Equivalent on 2006-01-31. Applicant: Planar Systems, Inc..

Clearance details

Applicant: Planar Systems, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2006-01-19
Decision date: 2006-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

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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 →

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