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Rod, Straight, Titanium, Ø5.5mm x 120mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution
- 00815730020163 ()
3RST55-120
- Trans-facet-screw internal spinal fixation system, sterile
Rod, Straight, Titanium, Ø5.5mm x 100mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution
- 00815730020149 ()
3RST55-100
- Trans-facet-screw internal spinal fixation system, sterile
Rod, Straight, Titanium, Ø5.5mm x 80mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution
- 00815730020125 ()
3RST55-80
- Trans-facet-screw internal spinal fixation system, sterile
Rod, Straight, Titanium, Ø5.5mm x 70mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution
- 00815730020101 ()
3RST55-70
- Trans-facet-screw internal spinal fixation system, sterile
No Description
NEW ERIE SCIENTIFIC LLC
Cover Slips
In Commercial Distribution
- 10810041333985 ()
- 00810041333988 ()
BB02400500P113MNZ1
- Microscope slide coverslip IVD
Pediatric Polypropylene Glaucoma Drainage Device
NEW WORLD MEDICAL, INCORPORATED
S3
Not in Commercial Distribution
- 00892064002140 ()
- Area/Surface Area: 85 Square millimeter
S3
- Eye valve
Ahmed Accessory Tube Extender
NEW WORLD MEDICAL, INCORPORATED
TE
In Commercial Distribution
- 00892064002188 ()
- Length: 4.8 Millimeter
- Width: 3 Millimeter
TE
- Glaucoma shunt, tubular, non-animal-derived
Event Reporting and Administrative AED Configuration Software V.2.2.1.1 for Powerheart G5
Zoll Medical Corporation
40-00296-05
In Commercial Distribution
- 00812394021505 ()
40-00296-05
- External defibrillator application software
MDLink SW 12.0
Zoll Medical Corporation
40-00580-01
In Commercial Distribution
- 00812394021499 ()
40-00580-01
- External defibrillator application software
MDLink SW 10.16
Zoll Medical Corporation
400621-046
400621-046
- External defibrillator application software
Event Reporting and Administrative AED Configuration Software V.2.1.1.0 for Powerheart G5
Zoll Medical Corporation
XAEDMGR01E
XAEDMGR01E
- External defibrillator application software
Event Reporting and Administrative AED Configuration Software V 2 0 5 0 for Powerheart G5
Cardiac Science Corporation
XAEDMGR01C
In Commercial Distribution
- 00812394020539 ()
XAEDMGR01C
- External defibrillator application software
MDLink SW 10.15
Cardiac Science Corporation
400621-045
In Commercial Distribution
- 00812394020393 ()
400621-045
- External defibrillator application software
Event Reporting and Administrative AED Configuration Software V.2.1.0.6 for Powerheart G5
Cardiac Science Corporation
XAEDMGR01D
In Commercial Distribution
- 00812394020188 ()
XAEDMGR01D
- External defibrillator application software
Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation
HEARTSINE TECHNOLOGIES LTD
1.4.0
In Commercial Distribution
- M727SAVEREVOH013 ()
PAD-ACC-03
- External defibrillator application software
Angio Workstation Software
CANON MEDICAL SYSTEMS CORPORATION
XIDF-AWS801
In Commercial Distribution
- 04987670100451 ()
- Diagnostic x-ray digital imaging system workstation application software
FerriSmart is a stand-alone software application that automatically analyses multi slice, spin echo MRI data sets encompassing the abdomen to determine the signal decay rate (R2) that is used to characterize iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentrations in vivo.
The software application is a measuring medical device intended to be hosted either in a cloud-based or on site hosted platform and used directly by the radiographer. It does not drive the MRI machine and does not come into direct contact with patients.
The result report provides the patient’s average LIC reported in micromole and milligram per gram dry weight of liver. The images analysed are included in the report for review by the radiologist. The results are intended to assist in clinical diagnosis, and/or in making decisions concerning clinical management.
FerriSmart is indicated to:
• measure liver iron concentration in individuals with confirmed or suspected systemic iron overload
• monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions
• aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v01
In Commercial Distribution
- 09369998038619 ()
- MRI system application software
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.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v2.0.0
In Commercial Distribution
- 09355529000095 ()
-
- MRI system application software
FerriSmart is a standalone software as a medical device indicated for the evaluation of liver R2 and liver iron concentration (LIC) from MRI images for the full spectrum of R2 and LIC known clinically. It automatically analyses multi slice, spin echo MRI data sets encompassing the abdomen to determine the signal decay rate (R2) that is used to characterize iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentrations in vivo.
The software application is intended to be hosted either in a cloud-based or on site hosted platform and used directly by the radiographer. It does not drive the MRI machine and does not come into direct contact with patients.
The result report provides the patient’s average LIC reported in micromole and milligram per gram dry weight of liver. The images analysed are included in the report for review by the radiologist. The results are intended to assist in clinical diagnosis, and/or in making decisions concerning clinical management.
FerriSmart is indicated to:
• Support clinical diagnoses in individuals with confirmed or suspected liver iron overload;
• Assessment of liver iron loading to support the subsequent clinical decision-making for patients under management of diseases such as thalassaemia disorders or hereditary haemochromatosis.
• Results, when interpreted by a trained physician can be used to support clinical diagnoses about the status of liver iron concentration, the subsequent clinical decision-making processes for the management of iron overload diseases.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v2.2.4
In Commercial Distribution
- 09355529000057 ()
-
- MRI system application software
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
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
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
Kosmos Application loaded on an iPad.
ECHONOUS, INC.
iOS 4.X
Not in Commercial Distribution
- 09353278000823 ()
- Ultrasound imaging system application software
KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution
- 09353278000762 ()
- Ultrasound imaging system application software
Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution
- 09353278000717 ()
- Ultrasound imaging system application software
Kosmos OTS Android Doppler Software Package
ECHONOUS, INC.
P007701
In Commercial Distribution
- 09353278000700 ()
- Ultrasound imaging system application software
Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007465
In Commercial Distribution
- 09353278000694 ()
- Ultrasound imaging system application software
Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007213
In Commercial Distribution
- 09353278000687 ()
- Ultrasound imaging system application software
Ultrasound imaging system application software
ECHONOUS, INC.
P006576
In Commercial Distribution
- 09353278000588 ()
- Ultrasound imaging system application software
No Description
KONICA MINOLTA, INC.
AEYC
In Commercial Distribution
- 04560141951914 ()
- Diagnostic x-ray digital imaging system workstation application software
No Description
KONICA MINOLTA, INC.
AEVE
In Commercial Distribution
- 04560141951426 ()
- Diagnostic x-ray digital imaging system workstation application software
No Description
KONICA MINOLTA, INC.
AEVD
In Commercial Distribution
- 04560141951419 ()
- Diagnostic x-ray digital imaging system workstation application software
No Description
KONICA MINOLTA, INC.
AE9A
In Commercial Distribution
- 04560141950849 ()
- Diagnostic x-ray digital imaging system workstation application software
No Description
KONICA MINOLTA, INC.
ACDY
In Commercial Distribution
- 04560141947788 ()
- Diagnostic x-ray digital imaging system workstation application software
No Description
KONICA MINOLTA, INC.
ACDX
In Commercial Distribution
- 04560141947771 ()
- Diagnostic x-ray digital imaging system workstation application software
No Description
KONICA MINOLTA, INC.
A4C1
In Commercial Distribution
- 04560141945166 ()
- Diagnostic x-ray digital imaging system workstation application software
No Description
RESOUNDANT, INC.
3.0DKR
In Commercial Distribution
- 00850011790199 ()
MREPLUSV3
- MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0WIN
Not in Commercial Distribution
- 00850011790014 ()
- MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0DKR
Not in Commercial Distribution
- 00850011790007 ()
- MRI system application software
Kit
ST. JUDE MEDICAL, INC.
Derexi™
In Commercial Distribution
- 05415067005861 ()
H700586
- Cardiac mapping system application software
Software Installation
ST. JUDE MEDICAL, INC.
100037184
In Commercial Distribution
- 05415067003027 ()
100037184
- Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700295
In Commercial Distribution
- 05415067002952 ()
H700295
- Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700293
In Commercial Distribution
- 05415067002938 ()
H700293
- Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700292
In Commercial Distribution
- 05415067002921 ()
H700292
- Cardiac mapping system application software
Software Installation
ST. JUDE MEDICAL, INC.
H700186
In Commercial Distribution
- 05415067001863 ()
H700186
- Cardiac mapping system application software
Software Upgrade Kit v.3.1
ST. JUDE MEDICAL, INC.
H700185
In Commercial Distribution
- 05415067001856 ()
H700185
- Cardiac mapping system application software
suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.7
Not in Commercial Distribution
- 00850001088008 ()
- MRI system application software
suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
5
In Commercial Distribution
- 00850001088015 ()
- MRI system application software
Software Upgrade Kitv.3.0.1.1
ST. JUDE MEDICAL, INC.
H21921
In Commercial Distribution
- 05414734219211 ()
H21921
- Cardiac mapping system application software
No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution
- 05414734214841 ()
75-06066-001
- Cardiac mapping system application software