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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 K190578
Device Name SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence
Applicant
Siemens Medical Solutions USA Inc.
40 Liberty Blvd.
Malvern,  PA  19355
Applicant Contact Kimberly Mangum
Correspondent
Siemens Medical Solutions USA Inc.
40 Liberty Blvd.
Malvern,  PA  19355
Correspondent Contact Maria Ebio
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/06/2019
Decision Date 06/27/2019
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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