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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
510(k) Number K253023
Device Name BIOGRAPH One
Applicant
Siemens Healthineers AG
Siemensstr. 3
Forchheim,  DE 91301
Applicant Contact Friederike Hertle
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Malvern,  PA  19355
Correspondent Contact Alina Goodman
Regulation Number892.1200
Classification Product Code
OUO  
Subsequent Product Codes
KPS   LNH   LNI   MOS  
Date Received09/19/2025
Decision Date 01/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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