EIGEN DSA 2000— 510(k) K063846

Substantially Equivalent

Eigen

FDA 510(k) clearance K063846 for EIGEN DSA 2000, Substantially Equivalent on 2007-01-26. Applicant: Eigen.

Clearance details

Applicant: Eigen
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2006-12-27
Decision date: 2007-01-26
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, 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.