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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 prioritization software for lesions
510(k) Number K191556
Device Name Red Dot
Behold.AI Technologies Limited
91-97 Bohemia Road
st. leonards-on-sea,  GB tn37 6rj
Applicant Contact simon rasalingham
Hogan Lovells US LPP
555 13th Street, NW
washington,  DC  20004
Correspondent Contact john j. smith
Regulation Number892.2080
Classification Product Code
Date Received06/12/2019
Decision Date 02/28/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No