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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 K233753
Device Name AI-Rad Companion (Pulmonary)
Applicant
Siemens Healthcare GmbH
Henkestrasse 127
Erlangen,  DE 91052
Applicant Contact Kira Morales
Correspondent
Siemens Healthcare GmbH
40 Liberty Boulevard
Malvern,  PA  19335
Correspondent Contact Kira Morales
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
QIH  
Date Received11/22/2023
Decision Date 03/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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