EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

PHILIPS ULTRASOUND, INC.

The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Epiq 5 Diagnostic Ultrasound System, Epiq 7diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK160807
510k NumberK160807
Device Name:EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant PHILIPS ULTRASOUND, INC. 3000 MINUTEMAN ROAD Andover,  MA  01810
ContactPeng Cui
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2016-03-24
Decision Date2016-04-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838074187 K160807 000
00884838097957 K160807 000
00884838097742 K160807 000

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