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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K253649
Device Name Spectral CT Verida Family
Applicant
Philips Medical Systems Technologies , Ltd.
Advanced Technology Center, Matam, Bldg. 34
Haifa,  IL 3100202
Applicant Contact Siwar Assi
Correspondent
Philips Medical Systems Technologies , Ltd.
Advanced Technology Center, Matam, Bldg. 34
Haifa,  IL 3100202
Correspondent Contact Siwar Assi
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/20/2025
Decision Date 03/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Clinical Trials NCT07108205
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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