QLAB WITH FHN AND VPQ PLUG-IN

System, Image Processing, Radiological

PHILIPS ULTRASOUND, INC.

The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Qlab With Fhn And Vpq Plug-in.

Pre-market Notification Details

Device IDK121223
510k NumberK121223
Device Name:QLAB WITH FHN AND VPQ PLUG-IN
ClassificationSystem, Image Processing, Radiological
Applicant PHILIPS ULTRASOUND, INC. 3000 MINUTEMAN RD. Andover,  MA  01810
ContactPenny Greco
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-04-23
Decision Date2012-05-15
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.