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510(k) Data Aggregation
K Number
K080961Device Name
NM APPLICATION SUITE
Manufacturer
PHILIPS NUCLEAR MEDICINE, INC
Date Cleared
2008-04-18
(14 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS NUCLEAR MEDICINE, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A nuclear medicine image display and processing application suite that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine gamma camera. The NM Application Suite should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
Device Description
The NM Application Suite is a Windows®-based Nuclear Medicine suite of image display and processing applications for the Nuclear Medicine market segment. The software package is deployable on hardware platforms, which meet the minimum requirements needed to run the software. The NM Application Suite includes both review and processing functionality and can be segmented into separate review and analysis configurations, such as a Planar and SPECT. The comprehensive tools and features provided with this product, will allow the technologist and/or physician to perform image review, processing of source data, post processing, hardcopy production, interpretation, report generation and contains the utilities necessary to support the workflow and data management between those activities. The system will support connectivity aspects necessary to import and export data as required to accomplish daily work scenarios.
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