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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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