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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 K253595
Device Name EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Applicant
Philips Ultrasound, LLC
22100 Bothell Everett Hwy.
Bothell,  WA  98021
Applicant Contact Lakshmi Sanjana Gondesi
Correspondent
Philips Ultrasound, LLC
22100 Bothell Everett Hwy.
Bothell,  WA  98021
Correspondent Contact Lakshmi Sanjana Gondesi
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ   QIH  
Date Received11/18/2025
Decision Date 03/27/2026
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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