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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 K201012
Device Name EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
Applicant
Philips Ultrasound, Inc.
22100 Bothell Everett Highway
Bothell,  WA  98021 -8431
Applicant Contact Deep Pal
Correspondent
Philips Ultrasound, Inc.
22100 Bothell Everett Highway
Bothell,  WA  98021 -8431
Correspondent Contact Deep Pal
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   QIH  
Date Received04/17/2020
Decision Date 05/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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