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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 K254205
Device Name Zenition 30
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 6
Best,  NL 5684PC
Applicant Contact Gyanendra Mani Tripathi
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 6
Best,  NL 5684PC
Correspondent Contact Gyanendra Mani Tripathi
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received12/29/2025
Decision Date 08/07/2026
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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