SEARCH RESULTS FOR: (*purchase New Brunswick driver*)(1822305 results)
Only the first 10,000 results were returned. Filter these results or refine your query. Some pre-built queries with more than 10,000 results are available for download.
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 04719875621130 ()
UT-0222-1Q
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 14719875621120 ()
- 04719875621123 ()
UT-0222-1P
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 14719875621113 ()
- 04719875621116 ()
UT-0222-KOL
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 14719875621106 ()
- 04719875621109 ()
UT-0222-50
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 14719875621090 ()
- 04719875621093 ()
UT-0222-1000
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 14719875621083 ()
- 04719875621086 ()
UT-0222-1Y
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 14719875621021 ()
- 04719875621024 ()
UT-0222-500
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 14719875621014 ()
- 04719875621017 ()
UT-0222-D
- Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution
- 04719875621000 ()
- 14719875621007 ()
UT-0222
- Ultrasound imaging 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
GRAFT SIZER
STRYKER CORPORATION
2000-004-051
In Commercial Distribution
- 04546540790989 ()
2000-004-051
- Ligament graft sizer, noninvasive
GRAFT SIZING GAUGE 8MM
STRYKER CORPORATION
234-020-087
In Commercial Distribution
- 04546540755889 ()
- Lumen/Inner Diameter: 8.0 Millimeter
234-020-087
- Ligament graft sizer, noninvasive
GRAFT SIZING GAUGE 7MM
STRYKER CORPORATION
234-020-086
In Commercial Distribution
- 04546540755872 ()
- Lumen/Inner Diameter: 7.0 Millimeter
234-020-086
- Ligament graft sizer, noninvasive
GRAFT SIZING GAUGE 6MM
STRYKER CORPORATION
234-020-085
In Commercial Distribution
- 04546540755865 ()
- Lumen/Inner Diameter: 6.0 Millimeter
234-020-085
- Ligament graft sizer, noninvasive
8.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-509
In Commercial Distribution
- 04546540755049 ()
- Lumen/Inner Diameter: 8.5 Millimeter
234-010-509
- Ligament graft sizer, noninvasive
6.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-507
In Commercial Distribution
- 04546540755025 ()
- Lumen/Inner Diameter: 6.5 Millimeter
234-010-507
- Ligament graft sizer, noninvasive
DRILL GUIDE/GRAFT SIZER, MODULAR ACL WORKSTATION
STRYKER CORPORATION
234-010-517
In Commercial Distribution
- 04546540755124 ()
234-010-517
- Ligament graft sizer, noninvasive
13MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-514
In Commercial Distribution
- 04546540755094 ()
- Lumen/Inner Diameter: 13.0 Millimeter
234-010-514
- Ligament graft sizer, noninvasive
12.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-513
In Commercial Distribution
- 04546540755087 ()
- Lumen/Inner Diameter: 12.5 Millimeter
234-010-513
- Ligament graft sizer, noninvasive
11.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-512
In Commercial Distribution
- 04546540755070 ()
- Lumen/Inner Diameter: 11.5 Millimeter
234-010-512
- Ligament graft sizer, noninvasive
10.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-511
In Commercial Distribution
- 04546540755063 ()
- Lumen/Inner Diameter: 10.5 Millimeter
234-010-511
- Ligament graft sizer, noninvasive
9.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-510
In Commercial Distribution
- 04546540755056 ()
- Lumen/Inner Diameter: 9.5 Millimeter
234-010-510
- Ligament graft sizer, noninvasive
7.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-508
In Commercial Distribution
- 04546540755032 ()
- Lumen/Inner Diameter: 7.5 Millimeter
234-010-508
- Ligament graft sizer, noninvasive
12MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-005
In Commercial Distribution
- 04546540754417 ()
- Lumen/Inner Diameter: 12.0 Millimeter
234-010-005
- Ligament graft sizer, noninvasive
11MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-004
In Commercial Distribution
- 04546540754400 ()
- Lumen/Inner Diameter: 11.0 Millimeter
234-010-004
- Ligament graft sizer, noninvasive
10MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-003
In Commercial Distribution
- 04546540754394 ()
- Lumen/Inner Diameter: 10.0 Millimeter
234-010-003
- Ligament graft sizer, noninvasive
9MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-002
In Commercial Distribution
- 04546540754387 ()
- Lumen/Inner Diameter: 9.0 Millimeter
234-010-002
- Ligament graft sizer, noninvasive
The Cydar EV software produces automated 3D overlays for use in endovascular surgery. The software detects vertebral anatomical information present in live X-ray images and matches ('registers') it to an existing CT scan of the patient in order to determine their precise position. This match then allows a 3D overlay to be generated in the correct position and projection. The Cydar EV software is hosted on cloud high-performance computers in order to accelerate performance
Cydar EV works with both flat panel detectors and image intensifiers on fixed and mobile X-ray sets. The Cydar EV Instructions for Use remain the same for all types of X-ray set.
Note: Federal law (US) restricts this device to sale by or on the order of a physician.
CYDAR LIMITED
EV-2
In Commercial Distribution
- 05060508110002 ()
- Angiographic x-ray system application software
Kit
ST. JUDE MEDICAL, INC.
Derexi™
In Commercial Distribution
- 05415067005861 ()
H700586
- Cardiac mapping system application software
X EP System Wave Speed Map Software License
ST. JUDE MEDICAL, INC.
ENSITE-WS-01
In Commercial Distribution
- 05415067038111 ()
ENSITE-WS-01
- Cardiac mapping system application software
Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-WS-01
In Commercial Distribution
- 05415067038098 ()
ENSITE-D-WS-01
- Cardiac mapping system application software
X EP System Omnipolar Technology Data Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTEXPORT-01
In Commercial Distribution
- 05415067037770 ()
ENSITE-OTEXPORT-01
- Cardiac mapping system application software
Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1
In Commercial Distribution
- 05415067037763 ()
ENSITE-SW-1.1
- Cardiac mapping system application software
X EP System LiveView Dynamic Display Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-LV-01
In Commercial Distribution
- 05415067037749 ()
ENSITE-D-LV-01
- Cardiac mapping system application software
X EP System Live Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-LE-01
In Commercial Distribution
- 05415067037732 ()
ENSITE-LE-01
- Cardiac mapping system application software
X EP System LiveView Dynamic Display Software License
ST. JUDE MEDICAL, INC.
ENSITE-LV-01
In Commercial Distribution
- 05415067037718 ()
ENSITE-LV-01
- Cardiac mapping system application software
X EP System Omnipolar Technology Software License
ST. JUDE MEDICAL, INC.
ENSITE-OT-01
In Commercial Distribution
- 05415067037701 ()
ENSITE-OT-01
- Cardiac mapping system application software
X EP System Omnipolar Technology Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-OT-01
In Commercial Distribution
- 05415067037695 ()
ENSITE-D-OT-01
- Cardiac mapping system application software
Software License
ST. JUDE MEDICAL, INC.
H702601
In Commercial Distribution
- 05415067033185 ()
H702601
- Cardiac mapping system application software