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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 K190072
Device Name BriefCase
Applicant
Aidoc Medical, Ltd.
92 Yigal Alon St.
tel aviv,  IL 67891
Applicant Contact nimrod epstein
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street, NW
washington,  DC  20004
Correspondent Contact john j. smith
Regulation Number892.2080
Classification Product Code
QAS  
Date Received01/15/2019
Decision Date 04/15/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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