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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 K200515
Device Name syngo.CT Cardiac Planning
Applicant
Siemens Medical Soultions USA, Inc.
2501 N. Barrington Rd.
Hiffman Estates,  IL  60192
Applicant Contact Veronica Padharia
Correspondent
Siemens Medical Soultions USA, Inc.
2501 N. Barrington Rd.
Hiffman Estates,  IL  60192
Correspondent Contact Veronica Padharia
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/02/2020
Decision Date 03/25/2020
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
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