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The CPI RAD VISION digital imaging system is a full-featured radiographic imaging system that is
designed to capture digital radiographic X-ray images in hospitals and clinics. Generator controls
for setting exposure factors and techniques are included along with the image acquisition functions.
Images are automatically pre-processed during acquisition, and further image processing may be
applied after the images have been acquired or stored. This allows the image(s) to be enhanced to
improve the visualization of anatomical details.
Images may be stored on the built-in hard disk, on optical disc (CD/DVD-R/RW), or on a DICOM 3.0
compliant network storage device.
This is a non-invasive device, designed to image the major systems of the body: Skull, neck, chest,
abdomen, pelvis, and extremities. It is not intended for mammographic, fluoroscopic, and / or
angiographic applications.
The CPI RAD VISION digital imaging system is intended for use with CPI CMP 200 DR or Indico
100 X-ray generators.
Communications & Power Industries Canada Inc
VZW2944M9
In Commercial Distribution
- 00885310000021 ()
- Stationary basic diagnostic x-ray system, digital
No Description
Siemens Healthcare GmbH
11574001
In Commercial Distribution
- 04056869962214 ()
- Stationary basic diagnostic x-ray system, digital
Lightweight, portable, state of the art three-component force platform, measuring the vertical ground reaction force and its point of application (CoP). Its large surface allows for any stance. It is sensitive enough to pick up the changes in the vertical ground reaction force produced by the beating of the heart and the blood ejection in the aorta (including the modulation produced by the breathing cycle), while the subject is standing on the top surface. It satisfies the International Society for Posture and Gait Research (ISPGR) recommendations for clinical posturography. It is intended to be used as aid in fall risk screening; posturography (static and dynamic); weight, balance, and postural control assessment; mechanography; physical performance investigations; and objective tracking of treatment efficacy and disease progress. Covered by one or more US patents.
VESTIBULAR TECHNOLOGIES, LLC
Professional
In Commercial Distribution
- B702P31C0 ()
P31C
- Biomechanical function analysis/interactive rehabilitation system
- Posturography system
- Posturography system platform
- Stand-on floor scale, electronic
E2 EasySet Mounting Hardware (pair) designed to install onto 1-1/4" back canes (includes E2 EasySet Mounting Pin Interface Brackets). Optional mounting hardware for Matrx E2 Backs (18H/20H). Quick-release (removable) design.
Motion Concepts Inc
E2PBMH-X
In Commercial Distribution
- 07540147001247 ()
E2PBMH-X
- Wheelchair back rest positioner
E2 EasySet Mounting Hardware (pair) designed to install onto 1-1/8" back canes (includes E2 EasySet Mounting Pin Interface Brackets). Optional mounting hardware for Matrx E2 Backs (18H/20H). Quick-release (removable) design.
Motion Concepts Inc
E2PBMH-Q
In Commercial Distribution
- 07540147001230 ()
E2PBMH-Q
- Wheelchair back rest positioner
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-LTP-01
In Commercial Distribution
- 04719878713801 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
MSI-ITH-01
In Commercial Distribution
- 04719878713733 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-NGC-04
In Commercial Distribution
- 04719878713573 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-NTR-02
In Commercial Distribution
- 04719878713528 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-RTR-02
In Commercial Distribution
- 04719878713337 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-CNS-02
In Commercial Distribution
- 04719878713085 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-DPS-00
In Commercial Distribution
- 04719878713016 ()
- Surgical planning/navigation-enhancement system
AmCAD UO is a PC based, self contained, non invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA cleared ultrasound system. The software is designed to support visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician’s evaluation and monitoring of the airway state.
AMCAD BIOMED CORPORATION
1.0
In Commercial Distribution
- 04719875623103 ()
UO-0102
- 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
- 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
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-NTR-04
In Commercial Distribution
- 04719878713542 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-NGC-03
In Commercial Distribution
- 04719878713511 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-DPS-04
In Commercial Distribution
- 04719878713207 ()
- Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-SSG-02
In Commercial Distribution
- 04719878713078 ()
- Surgical planning/navigation-enhancement system
Workstation
ST. JUDE MEDICAL, INC.
100026148
In Commercial Distribution
- 05414734031035 ()
100026148
- Cardiac mapping system
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
Monitor with DOX SPO2, NIBP, HR with Bluetooth
CRITICARE TECHNOLOGIES, INC.
eQuality 506DNB
In Commercial Distribution
- D438506DNBUS0 ()
- Multiple vital physiological parameter monitoring system, clinical
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
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
AcQMap to DiamondTemp Generator Adapter
ACUTUS MEDICAL, INC.
800727
Not in Commercial Distribution
- 00850027837253 ()
800727
- Cardiac mapping system
No Description
Exo Imaging, Inc.
EW1001
In Commercial Distribution
- 00850018318013 ()
- Ultrasound imaging system application software
VistaScan™ Software 1.x.x
EMAGINE SOLUTIONS TECHNOLOGY LLC
1.x.x
In Commercial Distribution
- 00850017464001 ()
- Ultrasound imaging system application software
jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution
- 00850014885021 ()
- Ultrasound imaging system application software
Software Application
Vave Health, Inc.
VUA
Not in Commercial Distribution
- 00850001977043 ()
VUA
- Ultrasound imaging 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