EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Philips Medical Systems

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Epiq Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK211597
510k NumberK211597
Device Name:EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Philips Medical Systems 22100 Bothell Everett HWY Bothell,  WA  98021
ContactBrenna Loufek
CorrespondentTamara Daniels
Philips Medical Systems 22100 Bothell Everett HWY Bothell,  WA  98021
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
Subsequent Product CodeOBJ
Subsequent Product CodeQIH
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-24
Decision Date2021-09-08

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