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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K190868
Device Name Cleerly Labs
Applicant
Cleerly Inc
101 Greenwich St, Suite 11C
New York,  NY  10006
Applicant Contact Kimberly Elmore
Correspondent
Cleerly Inc
101 Greenwich St, Suite 11C
New York,  NY  10006
Correspondent Contact Kimberly Elmore
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/03/2019
Decision Date 11/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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