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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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HepaFat-Scan - 09355529000040

Standalone software application to facilitate the import and visualization of multi slice, gradient echo MRI data sets encompassing the abdomen, with functionality independent of the MRI equipment, to provide objective and reproducible determination of the triglyceride fat fraction in magnetic resonance images of the liver. 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. HepaFat-Scan is a software device intended for quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver. 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.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
V1.1.0
In Commercial Distribution

  • 09355529000040 ()


  • MRI system application software

HepaFat-AI - 09355529000019

Standalone software platform 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. HepaFat-AI is intended for quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver, also known as volumetric liver fat fraction (VLFF). 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. HepaFat-AI is indicated to: • Assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade in individuals with confirmed or suspected fatty liver disease; • Monitor liver fat content in patients undergoing weight loss management; • Aid in the assessment and screening of living donors for liver transplant.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
V1.0.0
Not in Commercial Distribution

  • 09355529000019 ()


  • MRI system application software

FerriScan, Cardiac T2* - 09355529000002

Software tool to facilitate the import and visualization of multi slice, spin echo MRI data sets encompassing the liver and cardiac tissue, with functionality independent of the MRI equipment vendor. The operational principle is based on fitting signal decay curves to the image signal intensities at the different echo times for the MR data set on a voxel by voxel (3 D pixel) basis to determine transverse relaxation rate (R2) images, that may be further transformed by a defined calibration to provide a quantitative measure of liver iron concentrations in vivo and fitting signal decay curves to magnetic resonance image signal intensities acquired at different echo times on a voxel by voxel (3 D pixel) basis to determine the signal decay rate (R2*) and time (T2*) The obtained results can be used for the following purposes: 1. Supporting clinical diagnoses about the status of liver iron concentration and cardiac iron. 2. Supporting the subsequent clinical decision making processes. 3. Supporting the use in clinical research trials, directed at studying changes in liver iron concentration as a result of interventions. 4. It contains an image viewer for importing DICOM images, browsing through patient datasets, viewing images and performing region of interest analysis.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
4.0.0
In Commercial Distribution

  • 09355529000002 ()


  • MRI system application software

NA - 04931921131640

Central Monitoring Station
NIHON KOHDEN CORPORATION
PU-681RA
In Commercial Distribution

  • 04931921131640 ()
PU-681RA

  • Centralized patient monitor

NA - 04931921114858

Additional alarm indicator unit, cable length
NIHON KOHDEN CORPORATION
YS-098P2
In Commercial Distribution

  • 04931921114858 ()
YS-098P2

  • Centralized patient monitor

NA - 04931921114841

Additional alarm indicator unit, cable length
NIHON KOHDEN CORPORATION
YS-098P1
In Commercial Distribution

  • 04931921114841 ()
YS-098P1

  • Centralized patient monitor

NA - 04931921114834

VL cable set (Second), cable length
NIHON KOHDEN CORPORATION
YS-097P9
In Commercial Distribution

  • 04931921114834 ()
YS-097P9

  • Centralized patient monitor

NA - 04931921114827

VL cable set (Second), cable length
NIHON KOHDEN CORPORATION
YS-097P8
In Commercial Distribution

  • 04931921114827 ()
YS-097P8

  • Centralized patient monitor

NA - 04931921114810

VL cable set (Main), cable length
NIHON KOHDEN CORPORATION
YS-097P6
In Commercial Distribution

  • 04931921114810 ()
YS-097P6

  • Centralized patient monitor

NA - 04931921114803

VL cable set (Main), cable length
NIHON KOHDEN CORPORATION
YS-097P5
In Commercial Distribution

  • 04931921114803 ()
YS-097P5

  • Centralized patient monitor

NA - 04931921114445

POWER SUPPLY KIT FOR WS-960P
NIHON KOHDEN CORPORATION
SC-611R
In Commercial Distribution

  • 04931921114445 ()
SC-611RA

  • Centralized patient monitor

NA - 04931921114131

Central Monitoring Station
NIHON KOHDEN CORPORATION
PU-621R
In Commercial Distribution

  • 04931921114131 ()
PU-621RA

  • Centralized patient monitor

NA - 04931921107805

Alarm indicator, cable length
NIHON KOHDEN CORPORATION
YL-612P
In Commercial Distribution

  • 04931921107805 ()
YL-612P

  • Centralized patient monitor

Hepatogram Plus - 00850011790199

No Description
RESOUNDANT, INC.
3.0DKR
In Commercial Distribution

  • 00850011790199 ()
MREPLUSV3

  • MRI system application software

MREplus - 00850011790014

No Description
RESOUNDANT, INC.
MREplus 3.0.0WIN
Not in Commercial Distribution

  • 00850011790014 ()


  • MRI system application software

MREplus - 00850011790007

No Description
RESOUNDANT, INC.
MREplus 3.0.0DKR
Not in Commercial Distribution

  • 00850011790007 ()


  • MRI system application software

Exo Works - 00850018318013

No Description
Exo Imaging, Inc.
EW1001
In Commercial Distribution

  • 00850018318013 ()


  • Ultrasound imaging system application software

N/A - 07613327546347

Spine Guidance Sales Demo
Stryker Leibinger GmbH & Co. KG
81-81043
In Commercial Distribution

  • 07613327546347 ()
81-81043

  • Surgical planning/navigation-enhancement system

N/A - 07613327545883

Spine Guidance Software
Stryker Leibinger GmbH & Co. KG
6002-710-000
In Commercial Distribution

  • 07613327545883 ()
6002-710-000

  • Surgical planning/navigation-enhancement system

SpineMap Go - 07613327413007

SpineMap Go - SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81041
In Commercial Distribution

  • 07613327413007 ()
81-81041

  • Surgical planning/navigation-enhancement system

SpineMap Go - 07613327412994

SpineMap Go - SOFTWARE
Stryker Leibinger GmbH & Co. KG
6002-690-000
In Commercial Distribution

  • 07613327412994 ()
6002-690-000

  • Surgical planning/navigation-enhancement system

SpineMap Go - 07613327412987

SpineMap Go - ENABLE
Stryker Leibinger GmbH & Co. KG
6002-690-300
In Commercial Distribution

  • 07613327412987 ()
6002-690-300

  • Surgical planning/navigation-enhancement system

Q-Tel RMS - 00812345029888

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
33193-104-50
Not in Commercial Distribution

  • 00812345029888 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029871

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
33193-103-50
Not in Commercial Distribution

  • 00812345029871 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029864

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-BAA-XXAAX
Not in Commercial Distribution

  • 00812345029864 ()


  • Centralized patient monitor

Surveyor S12 - 00812345029833

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-JDG-BXAAX
Not in Commercial Distribution

  • 00812345029833 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029642

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELS-P-XX
Not in Commercial Distribution

  • 00812345029642 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029635

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELS-P-AC
Not in Commercial Distribution

  • 00812345029635 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029628

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELS-P-AB
Not in Commercial Distribution

  • 00812345029628 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029611

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELS-P-AA
Not in Commercial Distribution

  • 00812345029611 ()


  • Centralized patient monitor
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