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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 K210055
Device Name Cios Alpha
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard 65-1A
Malvern,  PA  19355
Applicant Contact Cordell Fields
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard 65-1A
Malvern,  PA  19355
Correspondent Contact Cordell Fields
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received01/08/2021
Decision Date 02/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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