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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 K261874
Device Name Syneris PACS v.1.0.1.0
Applicant
Syneris
1600 Steeles Ave. W., Suite 214
Concord,  CA L4K 4M2
Applicant Contact Lily Timonina
Correspondent
Syneris
1600 Steeles Ave. W., Suite 214
Concord,  CA L4K 4M2
Correspondent Contact Lily Timonina
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/05/2026
Decision Date 09/23/2026
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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