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Diacor, Inc. ZXL-APB-10 Zephyr Patient Positioning and Transfer System

Company Name
Diacor, Inc.
Catalog Number
ZXL-APB-10

Description

Zephyr HP Accessory - Baseplate for S-Style thermoplastic masks
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Pricing
Summary

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Out of Stock
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RESONANCE HEALTH ANALYSIS SERVICES PTY LTD - HepaFatSmart

Standalone software as medical device (SaMD) designed to automatically analyse within seconds magnetic resonance imaging (MRI) datasets to generate an estimate of the patient’s volumetric liver fat fraction (VLFF), converted into proton density fat fraction (PDFF) and steatosis grade. No user input is required for the analysis thus minimising the impact of human error on obtained results. HepaFatSmart is intended for the quantitative evaluation of volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF) and liver steatosis grading.It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver.When interpreted by a trained physician, the results provide information that can aid in diagnosis.HepaFatSmart is indicated to:• Support clinical diagnoses in individuals with confirmed or suspected fatty liver disease; • Assessment of liver fat content to support the subsequent clinical decision-making processes for patients under management of diseases such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), viral hepatitis. • Support the subsequent clinical decision-making processes for patients Results, when interpreted by a trained physician can be used to support clinical diagnoses about the status of liver fat content, the subsequent clinical decision-making processes for the management of fatty liver related diseases.
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Additional Details

Device Identifier
B237ZXLABP100
Is RX
Yes
Is Over the Counter
No
Requires Sterilization
No
Is Sterile
No
Is Single Use
No

Barcode Mapping

Unit of MeasurementEachesGTIN
Each1B237ZXLABP100