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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 K212616
Device Name Koios DS
Applicant
Koios Medical, Inc.
242 West 38th Street, 14th Floor
New York,  NY  10018
Applicant Contact Patricia Setti-Laperch
Correspondent
Koios Medical, Inc.
242 West 38th Street, 14th Floor
New York,  NY  10018
Correspondent Contact Patricia Setti-Laperch
Regulation Number892.2060
Classification Product Code
POK  
Subsequent Product Code
QIH  
Date Received08/18/2021
Decision Date 12/16/2021
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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