Artemis, Artemis TPO, Artemis MX— 510(k) K222222

Substantially Equivalent

Eigen

FDA 510(k) clearance K222222 for Artemis, Artemis TPO, Artemis MX, Substantially Equivalent on 2023-10-12. Applicant: Eigen.

Clearance details

Applicant: Eigen
Product code: Code QTZ
Advisory panel: Radiology
Date received: 2022-07-25
Decision date: 2023-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grass Valley, CA, US

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