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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 K254237
Device Name CCI PACS VIEWER (PACS-US-001)
Applicant
CliniComp, Intl.
9655 Towne Centre Dr.
San Diego,  CA  92121
Applicant Contact Dessi Lyakov
Correspondent
CliniComp, Intl.
9655 Towne Centre Dr.
San Diego,  CA  92121
Correspondent Contact Dessi Lyakov
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/29/2025
Decision Date 04/23/2026
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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