EPIQ 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 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK200304
510k NumberK200304
Device Name:EPIQ Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Philips Ultrasound, Inc. 22100 Bothell Everett Highway Bothell,  WA  98021 -8431
ContactLinda Schulz
CorrespondentPrithul Bom
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)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-02-06
Decision Date2020-03-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838093935 K200304 000

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