Omni Legend— 510(k) K221932

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K221932 for Omni Legend, Substantially Equivalent on 2022-09-02. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code KPS
Advisory panel: Radiology
Date received: 2022-07-01
Decision date: 2022-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat Hacarmel, IL

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