IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO— 510(k) K022292

Substantially Equivalent

Agfa Corp.

FDA 510(k) clearance K022292 for IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO, Substantially Equivalent on 2002-09-12. Applicant: Agfa Corp..

Clearance details

Applicant: Agfa Corp.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2002-07-15
Decision date: 2002-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brevard, NC, 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.