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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Medical Image
510(k) Number K242437
Device Name Smile Dx®
Applicant
Cube Click, Inc.
105 East 34 Street
Suite 231
New York,  NY  10016
Applicant Contact Richard Ricci
Correspondent
Innolitics
1101 West 34th St
#550
Austin,  TX  78705
Correspondent Contact Meritxell Martinez
Regulation Number892.2070
Classification Product Code
MYN  
Subsequent Product Code
LLZ  
Date Received08/16/2024
Decision Date 05/14/2025
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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