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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
Predetermined Change
Control Plan Authorized
No
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