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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 K153232
Device Name Cios Select
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
40 LIBERTY BLVD 65-1A
MALVERN,  PA  19355
Applicant Contact PATRICIA D JONES
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
40 LIBERTY BLVD 65-1A
MALVERN,  PA  19355
Correspondent Contact PATRICIA D JONES
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received11/09/2015
Decision Date 02/10/2016
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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