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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 K190896
Device Name BriefCase
Applicant
Aidoc Medical, Ltd.
92 Yigal Alon St.
tel-aviv,  IL 6789134
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 Received04/05/2019
Decision Date 05/31/2019
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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