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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K251110
Device Name EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Applicant
Philips Ultrasound LLC
22100 Bothell Everett Highway
Bothell,  WA  98021
Applicant Contact Vera Kong
Correspondent
Philips Ultrasound LLC
22100 Bothell Everett Highway
Bothell,  WA  98021
Correspondent Contact Vera Kong
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ   QIH  
Date Received04/11/2025
Decision Date 05/09/2025
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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