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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 K123584
Device Name SYNGO, CT BONE READING
Applicant
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Malvern,  PA  19355 -1406
Applicant Contact KIMBERLY MANGUM
Correspondent
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Malvern,  PA  19355 -1406
Correspondent Contact KIMBERLY MANGUM
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/21/2012
Decision Date 03/12/2013
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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