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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 K260488
Device Name MULTIX Impact; MULTIX Impact C
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Malvern,  PA  19355
Applicant Contact AnnTina Walker
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Malvern,  PA  19355
Correspondent Contact AnnTina Walker
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received02/13/2026
Decision Date 08/31/2026
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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