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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 K254186
Device Name Azurion R3.1
Applicant
Philips Medical Systems B.V.
Veenpluis 6
Bldg. Qp
Best,  NL 5684PC
Applicant Contact Supriya Dalvi
Correspondent
Philips Medical Systems B.V.
Veenpluis 6
Bldg. Qp
Best,  NL 5684PC
Correspondent Contact Supriya Dalvi
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received12/23/2025
Decision Date 01/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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