Aurora— 510(k) K251153

Substantially Equivalent

Ge Medical Systems Israel

FDA 510(k) clearance K251153 for Aurora, Substantially Equivalent on 2025-06-12. Applicant: Ge Medical Systems Israel.

Clearance details

Applicant: Ge Medical Systems Israel
Product code: Code KPS
Advisory panel: Radiology
Date received: 2025-04-14
Decision date: 2025-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat Hacarmel, IL

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