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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 K240844
Device Name Spectral CT 7500 RT
Applicant
Philips Medical Systems Technologies , Ltd.
Advanced Technology Center, Bldg. 34, Matam
Haifa,  IL 3100200
Applicant Contact Siwar Assi
Correspondent
Philips Medical Systems Technologies , Ltd.
Advanced Technology Center, Bldg. 34, Matam
Haifa,  IL 3100200
Correspondent Contact Siwar Assi
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/27/2024
Decision Date 10/18/2024
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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