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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 K232420
Device Name Zenition 30
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 6
5684 Pc
Best,  NL
Applicant Contact Gyanendra Mani Tripathi
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 6
5684 Pc
Best,  NL
Correspondent Contact Gyanendra Mani Tripathi
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received08/11/2023
Decision Date 02/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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