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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K173420
Device Name Radiomics App v1.0
Applicant
Microsoft Corp.
1 Microsoft Way
Redmond,  WA  98052
Applicant Contact Ivan Tarapov
Correspondent
Biologics Consulting Group, Inc.
1555 King Street, Suite 300
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/01/2017
Decision Date 12/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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