QLAB QUANTIFICATION SOFTWARE

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 Quantification Software.

Pre-market Notification Details

Device IDK132165
510k NumberK132165
Device Name:QLAB QUANTIFICATION SOFTWARE
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 Received2013-07-12
Decision Date2013-08-09
Summary:summary

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