BIOGRAPH One— 510(k) K253023

Substantially Equivalent

Siemens Healthineers AG

FDA 510(k) clearance K253023 for BIOGRAPH One, Substantially Equivalent on 2026-01-15. Applicant: Siemens Healthineers AG.

Clearance details

Applicant: Siemens Healthineers AG
Product code: Code OUO
Advisory panel: Radiology
Date received: 2025-09-19
Decision date: 2026-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Forchheim, DE

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