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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K221281
Device Name Multitom Rax
Applicant
Siemens Medical Solutions
40 Liberty Boulevard
Malvern,  PA  19355
Applicant Contact Denise Adams
Correspondent
Siemens Medical Solutions
40 Liberty Boulevard
Malvern,  PA  19355
Correspondent Contact Denise Adams
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   JAK  
Date Received05/03/2022
Decision Date 11/17/2022
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
Recalls CDRH Recalls
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