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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K231833
Device Name Biograph Vision.X and Biograph Vision.X Edge
Applicant
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Road
Hoffman Estates,  IL  60192
Applicant Contact Alaine Medio
Correspondent
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Road
Hoffman Estates,  IL  60192
Correspondent Contact Alaine Medio
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received06/22/2023
Decision Date 07/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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