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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 K213700
Device Name MULTIX Impact, MULTIX Impact C
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern,  PA  19355
Applicant Contact Denise Adams
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern,  PA  19355
Correspondent Contact Denise Adams
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received11/23/2021
Decision Date 12/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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