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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K153360
Device Name ADMIRE
Applicant
Siemens Medi Cal Solutions, Inc.
40 Liberty Blvd., Mailcode 65-1a
Malvern,  PA  19355
Applicant Contact JOHN URTZ
Correspondent
Siemens Medi Cal Solutions, Inc.
40 Liberty Blvd., Mailcode 65-1a
Malvern,  PA  19355
Correspondent Contact JOHN URTZ
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/20/2015
Decision Date 06/29/2016
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
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