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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K253574
Device Name SOMATOM X.cite; SOMATOM X.ceed
Applicant
Siemens Medical Solutions USA, Inc.
810 Innovation Dr.
Knoxville,  TN  37932
Applicant Contact Kenny M Bello
Correspondent
Siemens Medical Solutions USA, Inc.
810 Innovation Dr.
Knoxville,  TN  37932
Correspondent Contact Kenny M Bello
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/17/2025
Decision Date 03/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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