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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 K212212
Device Name Multitom Rax with True2scale Body Scan Option
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 Code
JAA  
Date Received07/15/2021
Decision Date 02/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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