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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 K251072
Device Name Segmentron Viewer
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 Number892.2050
Classification Product Code
QIH  
Date Received04/07/2025
Decision Date 09/09/2025
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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