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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 K242130
Device Name Koios DS
Applicant
Koios Medical, Inc.
242 West 38th Street
14th Floor
New York,  NY  10018
Applicant Contact Michael Bocchinfuso
Correspondent
Koios Medical, Inc.
242 West 38th Street
14th Floor
New York,  NY  10018
Correspondent Contact Michael Bocchinfuso
Regulation Number892.2060
Classification Product Code
POK  
Subsequent Product Code
QIH  
Date Received07/22/2024
Decision Date 11/15/2024
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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