IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION— 510(k) K081976

Substantially Equivalent

Agfa Healthcare Corporation

FDA 510(k) clearance K081976 for IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION, Substantially Equivalent on 2008-07-28. Applicant: Agfa Healthcare Corporation.

Clearance details

Applicant: Agfa Healthcare Corporation
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2008-07-11
Decision date: 2008-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenville, SC, US

Download summary PDF View on FDA.gov ↗

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.