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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 K161196
Device Name SOMATOM Drive
Applicant
Siemens Medical Solutions USA, Inc.
65 Valley Stream Parkway
Malvern,  PA  19355
Applicant Contact Kimberly Mangum
Correspondent
Siemens Medical Solutions USA, Inc.
65 Valley Stream Parkway
Malvern,  PA  19355
Correspondent Contact Kimberly Mangum
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/27/2016
Decision Date 08/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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