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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Triage And Notification Software
510(k) Number K192167
Device Name CuraRad-ICH
Applicant
CuraCloud Corp.
999 Third Ave, Suite 700
Seattle,  WA  98104
Applicant Contact Xiaoxiao Liu
Correspondent
Manatt, Phelps & Phillips, LLP
One Embarcadero Center
30th Floor
San Francisco,  CA  94111
Correspondent Contact Yarmela Pavlovic
Regulation Number892.2080
Classification Product Code
QAS  
Date Received08/09/2019
Decision Date 04/13/2020
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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