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510(k) Data Aggregation
K Number
K071195Device Name
KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5
Manufacturer
Date Cleared
2007-06-20
(51 days)
Product Code
Regulation Number
892.1100Why did this record match?
Applicant Name (Manufacturer) :
ANI-KAL II, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
KHBS is an "Off the Shelf" software used for quantitative analysis of liver and gallbladder function studies obtains with a scintillation is treaters. The Dicom image data obtained with the scintillation gaments camera is transferred to the software loaded on to a network PC and analyzed by a person familiar with the use of nuclear medicine equipment.
Device Description
KHBS is an Off the Shelf nuclear hepatology software written on JAVA platform that can be loaded on to a PC. It is used for quantitative analysis and display of planar dicom image data acquired using scintillation gamma camera. The system generates time activity/curves and provides quantitative results of the liver and gallbladder function. It displays images, curves and texts in grey scale or color.
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