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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, Stationary
510(k) Number K233543
Device Name YSIO X.pree
Applicant
Siemens Medical Solutions
40 Liberty Boulevard
Malvern,  PA  19355
Applicant Contact Camila Rodriguez Valentin
Correspondent
Siemens Medical Solutions
40 Liberty Boulevard
Malvern,  PA  19355
Correspondent Contact Camila Rodriguez Valentin
Regulation Number892.1680
Classification Product Code
KPR  
Date Received11/03/2023
Decision Date 05/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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