EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify 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 Series, Affiniti Diagnostic Ultrasound System Series, Cx50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK201012
510k NumberK201012
Device Name:EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Philips Ultrasound, Inc. 22100 Bothell Everett Highway Bothell,  WA  98021 -8431
ContactDeep Pal
CorrespondentDeep Pal
Philips Ultrasound, Inc. 22100 Bothell Everett Highway Bothell,  WA  98021 -8431
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
Subsequent Product CodeQIH
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-17
Decision Date2020-05-01

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