Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti 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 Philips Epiq Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK212704
510k NumberK212704
Device Name:Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Philips Medical Systems 22100 Bothell Everett HWY Bothell,  WA  98021
ContactBrenna Loufek
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
Subsequent Product CodeOBJ
Subsequent Product CodeQIH
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-08-26
Decision Date2021-09-24

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