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510(k) Data Aggregation
K Number
K120525Device Name
QLAB QUANTIFICATION SOFTWARE
Manufacturer
PHILIPS HEALTHCARE GROUP
Date Cleared
2012-03-09
(16 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS HEALTHCARE GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QLAB Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
Device Description
OLAB Quantification software is available either as a stand-alone product that can function on a standard.PC, on board a dedicated workstation, or on-board Philips' ultrasound systems. It can be used by trained healthcare professionals for the on-line and off-line review and quantification of ultrasound studies in healthcare facilities/hospitals.
The QLAB Quantification software application package is designed to view and quantify image data acquired on Philips ultrasound products. Cardiac Motion Quantification (CMQ) is a plug-in included in Philips QLAB Quantification software.
The CMO plug-in is an application within OLAB intended to provide cardiac motion quantification. OLAB Quantification software is intended for use in healthcare facilities/hospitals by trained healthcare professionals.
OLAB CMO modifications were implemented to provide clients with improved reproducibility and consistency between users, as well as to provide users with a reduction of workflow steps. The modifications described in this Special 510(k) submission do not alter the intended use of the OLAB Quantification software with the CMO plug-in.
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