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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
Applicant
Behold.Ai Technologies Limited
91-97 Bohemia Rd.
St. Leonards-On-Sea,  GB TN37 6RJ
Applicant Contact Simon Rasalingham
Correspondent
Hogan Lovells US Lpp
555 13th St., NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2080
Classification Product Code
QFM  
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
Predetermined Change
Control Plan Authorized		 No
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