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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 K233657
Device Name NAEOTOM Alpha
Applicant
Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville,  TN  37932
Applicant Contact Tabitha Estes
Correspondent
Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville,  TN  37932
Correspondent Contact Tabitha Estes
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/14/2023
Decision Date 03/28/2024
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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