EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900— 510(k) K063029

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K063029 for EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900, Substantially Equivalent on 2006-11-02. Applicant: E-Z-Em, Inc..

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2006-10-02
Decision date: 2006-11-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Westbury, NY, US

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Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.