Artemis— 510(k) K162474

Substantially Equivalent

Eigen

FDA 510(k) clearance K162474 for Artemis, Substantially Equivalent on 2016-10-21. Applicant: Eigen.

Clearance details

Applicant: Eigen
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2016-09-06
Decision date: 2016-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grass Valley, 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.