AI-Rad Companion Brain MR— 510(k) K253057

Substantially Equivalent

Siemens Healthcare GmbH

FDA 510(k) clearance K253057 for AI-Rad Companion Brain MR, Substantially Equivalent on 2026-01-22. Applicant: Siemens Healthcare GmbH.

Clearance details

Applicant: Siemens Healthcare GmbH
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-09-22
Decision date: 2026-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Erlangen, DE

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