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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
510(k) Number K190442
Device Name Koios DS for Breast
Applicant
Koios Medical, Inc.
500 7th Avenue, 8th Floor
New York,  NY  10018
Applicant Contact Lev Barinov
Correspondent
Koios Medical, Inc.
500 7th Avenue, 8th Floor
New York,  NY  10018
Correspondent Contact Lev Barinov
Regulation Number892.2060
Classification Product Code
POK  
Subsequent Product Code
LLZ  
Date Received02/25/2019
Decision Date 07/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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