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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K242338
Device Name Cleerly LABS (v2.0)
Applicant
Cleerly, Inc.
1099 18th St., Suite 2860
Denver,  CO  80202
Applicant Contact Kristen DeJeu
Correspondent
Cleerly, Inc.
1099 18th St., Suite 2860
Denver,  CO  80202
Correspondent Contact Felicia Hosey
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received08/07/2024
Decision Date 03/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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