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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ENDOPRO IQ CITRIX/VIRTUALIZATION LICENSE
PENTAX OF AMERICA, INC.
M70204-UP
In Commercial Distribution

  • 04961333243471 ()


  • Radiology information system
ENDOPRO IQ CITRIX/VIRTUALIZATION LICENSE
PENTAX OF AMERICA, INC.
M70204
In Commercial Distribution

  • 04961333243464 ()


  • Radiology information system
MATROX ORION HD CAPTURE CARD
PENTAX OF AMERICA, INC.
M30126
In Commercial Distribution

  • 04961333243440 ()


  • Radiology information system
MATROX VIO CAPTURE CARD
PENTAX OF AMERICA, INC.
M30119
In Commercial Distribution

  • 04961333243433 ()


  • Radiology information system
IMAGE CAPTURE PC
PENTAX OF AMERICA, INC.
KBM68406
In Commercial Distribution

  • 04961333243235 ()


  • Radiology information system
HD SDI IMAGE CAPTURE PC
PENTAX OF AMERICA, INC.
KBM68404
In Commercial Distribution

  • 04961333243228 ()


  • Radiology information system
HD DVI IMAGE CAPTURE PC
PENTAX OF AMERICA, INC.
KBM68403
In Commercial Distribution

  • 04961333243211 ()


  • Radiology information system
IMAGE CAPTURE PC
PENTAX OF AMERICA, INC.
KBM68401
Not in Commercial Distribution

  • 04961333243204 ()


  • Radiology information system
ASSY: SERVER, RACK MOUNT FORM FACTOR
PENTAX OF AMERICA, INC.
KBM68312
In Commercial Distribution

  • 04961333243198 ()


  • Radiology information system
ASSY: SERVER, TOWER FORM FACTOR
PENTAX OF AMERICA, INC.
KBM68311
In Commercial Distribution

  • 04961333243181 ()


  • Radiology information system
ASSY: REVIEW/SCHEDULING PC
PENTAX OF AMERICA, INC.
KBM68307
In Commercial Distribution

  • 04961333243174 ()


  • Radiology information system
ASSY: ECAP NTSC 6 CHANNEL
PENTAX OF AMERICA, INC.
KBM68306
In Commercial Distribution

  • 04961333243167 ()


  • Radiology information system
ASSY: MPS DV/SD CAPTURE
PENTAX OF AMERICA, INC.
KBM68303
In Commercial Distribution

  • 04961333243150 ()


  • Radiology information system
HL7 INTERFACE OUTBOUND
PENTAX OF AMERICA, INC.
9269
In Commercial Distribution

  • 04961333236763 ()


  • Radiology information system
HL7 INTERFACE INBOUND
PENTAX OF AMERICA, INC.
9267
In Commercial Distribution

  • 04961333236756 ()


  • Radiology information system
ENDOPORTAL UPGRADE
PENTAX OF AMERICA, INC.
9265
In Commercial Distribution

  • 04961333236749 ()


  • Radiology information system
ENDOPORTAL
PENTAX OF AMERICA, INC.
9263
In Commercial Distribution

  • 04961333236732 ()


  • Radiology information system
DICOM INTERFACE FOR STROBE
PENTAX OF AMERICA, INC.
9251
In Commercial Distribution

  • 04961333236725 ()


  • Radiology information system
DICOM INTERFACE FOR SWALLOWING
PENTAX OF AMERICA, INC.
7251
In Commercial Distribution

  • 04961333236701 ()


  • Radiology information system
KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.
KOWA COMPANY,LTD.
VK28U2E
Not in Commercial Distribution

  • 04987646808947 ()


  • Medical image management system
KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.
KOWA COMPANY,LTD.
VK28UE
Not in Commercial Distribution

  • 04987646808930 ()


  • Medical image management system
KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.
KOWA COMPANY,LTD.
VK28K
Not in Commercial Distribution

  • 04987646808923 ()


  • Medical image management system
jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • 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
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
Software Application
Vave Health, Inc.
VUA
Not in Commercial Distribution

  • 00850001977043 ()
VUA

  • Ultrasound imaging system application software
No Description
Xandar Kardian Korea Inc.
XK300
Not in Commercial Distribution

  • 08809988780001 ()


  • Multiple vital physiological parameter monitoring system, home-use
Remidio Connect is web-based application it is intended for displaying, storing images and data from Remidio ophthalmic imaging devices to aid in screening of eye disease.
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
Remidio Connect
In Commercial Distribution

  • 08906096520069 ()


  • Medical image management system
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
Central Monitoring Station
NIHON KOHDEN CORPORATION
PU-681RA
In Commercial Distribution

  • 04931921131640 ()
PU-681RA

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

  • 04931921114858 ()
YS-098P2

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

  • 04931921114841 ()
YS-098P1

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

  • 04931921114834 ()
YS-097P9

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

  • 04931921114827 ()
YS-097P8

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

  • 04931921114810 ()
YS-097P6

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

  • 04931921114803 ()
YS-097P5

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

  • 04931921114445 ()
SC-611RA

  • Centralized patient monitor
Central Monitoring Station
NIHON KOHDEN CORPORATION
PU-621R
In Commercial Distribution

  • 04931921114131 ()
PU-621RA

  • Centralized patient monitor
Alarm indicator, cable length
NIHON KOHDEN CORPORATION
YL-612P
In Commercial Distribution

  • 04931921107805 ()
YL-612P

  • Centralized patient monitor
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
No Description
Exo Imaging, Inc.
EW1001
In Commercial Distribution

  • 00850018318013 ()


  • Ultrasound imaging system application software
Spine Guidance Sales Demo
Stryker Leibinger GmbH & Co. KG
81-81043
In Commercial Distribution

  • 07613327546347 ()
81-81043

  • Surgical planning/navigation-enhancement system
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 - SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81041
In Commercial Distribution

  • 07613327413007 ()
81-81041

  • Surgical planning/navigation-enhancement system
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