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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 K240224
Device Name Zenition 90
Applicant
Philips Medical Systems Nederlands B.V.
Veenpluis 6
Best,  NL 5684PC
Applicant Contact Rahul Kumar Sinha
Correspondent
Philips Medical Systems Nederlands B.V.
Veenpluis 6
Best,  NL 5684PC
Correspondent Contact Rahul Kumar Sinha
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received01/26/2024
Decision Date 05/22/2024
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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