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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 K152928
Device Name Multitom Rax
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
40 LIBERTY BLVD
MALVERN,  PA  19355
Applicant Contact DARREN A. DORMAN
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
40 LIBERTY BLVD
MALVERN,  PA  19355
Correspondent Contact DARREN A. DORMAN
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received10/05/2015
Decision Date 11/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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