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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 K163120
Device Name EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System
Applicant
Philips Ultrasound, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact Peng Cui
Correspondent
Philips Ultrasound, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Peng Cui
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received11/08/2016
Decision Date 01/10/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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