DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY— 510(k) K032638

Substantially Equivalent

Planar Systems, Inc.

FDA 510(k) clearance K032638 for DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY, Substantially Equivalent on 2003-09-11. Applicant: Planar Systems, Inc..

Clearance details

Applicant: Planar Systems, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2003-08-27
Decision date: 2003-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, 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.