EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)— 510(k) K053281

Substantially Equivalent

Emageon, Inc.

FDA 510(k) clearance K053281 for EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE), Substantially Equivalent on 2005-12-07. Applicant: Emageon, Inc..

Clearance details

Applicant: Emageon, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2005-11-25
Decision date: 2005-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, 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.