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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 K260497
Device Name DEEPVESSEL Plaque
Applicant
Keya Medical Technology Co., Ltd.
#1502-1, 1502-2, 1502-3, Floor 15, Bldg. 1, Yard #1, Ronghua
Beijing,  CN 100176
Applicant Contact Ning Li
Correspondent
Hogan Lovells
1735 Market St., Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Kelliann Payne
Regulation Number892.2050
Classification Product Code
QIH  
Date Received02/13/2026
Decision Date 06/04/2026
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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