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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 K260231
Device Name MiPACS V5 (1.0.0)
Applicant
Apryse Software Corp
2399 Blake St.
Denver,  CO  80205
Applicant Contact Hilal Chami
Correspondent
Apryse Software Corp
2399 Blake St.
Denver,  CO  80205
Correspondent Contact Hilal Chami
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/26/2026
Decision Date 06/25/2026
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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