AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS— 510(k) K042353

Substantially Equivalent

National Display Systems

FDA 510(k) clearance K042353 for AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS, Substantially Equivalent on 2004-11-24. Applicant: National Display Systems.

Clearance details

Applicant: National Display Systems
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2004-08-30
Decision date: 2004-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgan Hill, CA, 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.