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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K253670
Device Name SmartCT (R3.0 (L10))
Applicant
Philips Medical Systems B.V.
Veenpluis 6
Bldg. Qp
Best,  NL 5684PC
Applicant Contact Jeroen de Schrijver
Correspondent
Philips Medical Systems B.V.
Veenpluis 6
Bldg. Qp
Best,  NL 5684PC
Correspondent Contact Jeroen de Schrijver
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAK   LLZ  
Date Received11/21/2025
Decision Date 07/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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