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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 K252934
Device Name Diagnocat
Applicant
DGNCT, LLC
333 Southeast 2nd Ave.
Miami,  FL  33131
Applicant Contact Anastasya Melnikov
Correspondent
Hogan Lovells US LLP
1735 Market St., Floor 23
Philadelphia,  PA  19103
Correspondent Contact Kelliann Payne
Regulation Number892.2070
Classification Product Code
MYN  
Date Received09/15/2025
Decision Date 01/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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