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BD® HLA-B27 Application Module v1.0
BECTON, DICKINSON AND COMPANY
640776
Not in Commercial Distribution
- 00382906407764 ()
640776
- Laboratory instrument/analyser application software IVD
BD Synapsys™ Informatics Solution
BECTON, DICKINSON AND COMPANY
444139
In Commercial Distribution
- 00382904441395 ()
444139
- Laboratory instrument/analyser application software IVD
CellQuest Pro 4.0.2 Full Pack USB
BECTON, DICKINSON AND COMPANY
347527
Not in Commercial Distribution
- 00382903475278 ()
347527
- Laboratory instrument/analyser application software IVD
CellQuest Pro 4.0.2 Upgrade USB
BECTON, DICKINSON AND COMPANY
347526
Not in Commercial Distribution
- 00382903475261 ()
347526
- Laboratory instrument/analyser application software IVD
Retic-Count Upgrade Version 1.1
BECTON, DICKINSON AND COMPANY
343173
Not in Commercial Distribution
- 00382903431731 ()
343173
- Laboratory instrument/analyser application software IVD
Retic-Count S/W Version 1.1
BECTON, DICKINSON AND COMPANY
343130
Not in Commercial Distribution
- 00382903431304 ()
343130
- Laboratory instrument/analyser application software IVD
Procount Version 2.1 S/W
BECTON, DICKINSON AND COMPANY
341158
Not in Commercial Distribution
- 00382903411580 ()
341158
- Laboratory instrument/analyser application software IVD
No Description
TOPCON CORPORATION
SP-1P
In Commercial Distribution
- 04562123288315 ()
- Eye anterior segment analyser
Torrent Suite Dx SW, Installer V5.14.2
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A40001728
In Commercial Distribution
- 10190302019958 ()
- Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A40002323
In Commercial Distribution
- 10190302019859 ()
- Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A59789
In Commercial Distribution
- 10190302019514 ()
- Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A58343
In Commercial Distribution
- 10190302019408 ()
- Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES CORPORATION
A54068
In Commercial Distribution
- 10190302017978 ()
- Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES CORPORATION
A54067, V1.2.0
In Commercial Distribution
- 10190302017961 ()
- Laboratory instrument/analyser application software IVD
SW Installer
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A52422
In Commercial Distribution
- 10190302017848 ()
- Laboratory instrument/analyser application software IVD
ODXTT UG & ADF V10.0 USB - USA
LIFE TECHNOLOGIES CORPORATION
A51694
In Commercial Distribution
- 10190302017756 ()
- Human genomic analysis interpretive software
KIT,USB DIOMNI SW V2.0.0
LIFE TECHNOLOGIES CORPORATION
A53120
In Commercial Distribution
- 10190302017701 ()
- Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES CORPORATION
A52570, V1.1.0
In Commercial Distribution
- 10190302017312 ()
- Laboratory instrument/analyser application software IVD
KIT,TS DX SW,V5.12.5 INSTALLER
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A46166
In Commercial Distribution
- 10190302016810 ()
- Laboratory instrument/analyser application software IVD
ODXTT UG & ADF V3.6 USB-US
LIFE TECHNOLOGIES CORPORATION
A49678
In Commercial Distribution
- 10190302015646 ()
- Human genomic analysis interpretive software
KIT,QS DX SW V1.0.4
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A48389
In Commercial Distribution
- 10190302015615 ()
- Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES CORPORATION
A48166, V1.0.0
In Commercial Distribution
- 10190302015554 ()
- Laboratory instrument/analyser application software IVD
KIT, USB QS5 DX SW V1.1.0
LIFE TECHNOLOGIES CORPORATION
A47982, V1.0.0
In Commercial Distribution
- 10190302015479 ()
- Laboratory instrument/analyser application software IVD
KIT, SW 3500DX DCSV3.2-IVD
LIFE TECHNOLOGIES CORPORATION
A41856
In Commercial Distribution
- 10190302015066 ()
- Laboratory instrument/analyser application software IVD
KIT, TS DX SW, V5.8 INSTALLER
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A36601
In Commercial Distribution
- 10190302014090 ()
- Laboratory instrument/analyser application software IVD
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
KIT,QS DX SW V1.0.3
LIFE TECHNOLOGIES CORPORATION
1.0.3
In Commercial Distribution
- 10190302006729 ()
- Laboratory instrument/analyser application software IVD
ODXTT UG AND ADF 1.8 - US
LIFE TECHNOLOGIES CORPORATION
A32461
In Commercial Distribution
- 10190302006071 ()
- Human genomic analysis interpretive software
KIT, TS DX SW V5.6.4
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A33178
In Commercial Distribution
- 10190302005654 ()
- Laboratory instrument/analyser application software IVD
KIT,QS DX EM PATHOG IVD V1.0.1
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
1.0.1
In Commercial Distribution
- 10190302006736 ()
- Laboratory instrument/analyser application software IVD
No Description
ECHOIQ LIMITED
1.5.0
In Commercial Distribution
- 09309001128005 ()
- Cardiovascular interpretive screening software
This media contains V 7.5 of the following registered Medical Devices:
(DI)09120052070996 (SOFTWARE MAGELLAN V 7.X),
(DI)09120052071009 (SOFTWARE MAGELLAN TRACKER V 7.X)
Tecan Austria GmbH
30231095 00
In Commercial Distribution
- 09120052071504 ()
- 09120052071511 ()
- 09120052071528 ()
- 09120052071535 ()
- 09120052071542 ()
- 09120052071559 ()
- 09120052071566 ()
30231095
- Laboratory instrument/analyser application software IVD
This media contains V 7.4 of the following registered Medical Devices:
(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),
(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
Tecan Austria GmbH
30220141 00
In Commercial Distribution
- 09120052071351 ()
- 09120052071368 ()
- 09120052071375 ()
- 09120052071382 ()
- 09120052071399 ()
- 09120052071450 ()
- 09120052071467 ()
30220141
- Laboratory instrument/analyser application software IVD
This Media contains V7.5 of the following registered Medical Devices: (DI)09120052070880 SOFTWARE MAGELLAN PRO V7.x, (DI)09120052070910 SOFTWARE MAGELLAN PRO TRACKER V7.x
Tecan Austria GmbH
30219868 00
In Commercial Distribution
- 09120052071344 ()
- 09120052071320 ()
- 09120052071337 ()
- 09120052071474 ()
- 09120052071481 ()
- 09120052071573 ()
30219868
- Laboratory instrument/analyser application software IVD
This media contains V 7.5 of the following registered Medical Devices:
(DI)09120052070996 (SOFTWARE MAGELLAN V 7.X),
(DI)09120052071009 (SOFTWARE MAGELLAN TRACKER V 7.X)
Tecan Austria GmbH
30204301 00
Not in Commercial Distribution
- 09120052071269 ()
- 09120052071238 ()
- 09120052071276 ()
- 09120052071283 ()
- 09120052071290 ()
- 09120052071306 ()
- 09120052071313 ()
- 09120052071412 ()
- 09120052071429 ()
- 09120052071436 ()
- 09120052071443 ()
30204301
- Laboratory instrument/analyser application software IVD
This media contains V 7.4 of the following registered Medical Devices:
(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),
(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
Tecan Austria GmbH
30185384 00
Not in Commercial Distribution
- 09120052071108 ()
- 09120052071092 ()
- 09120052071115 ()
- 09120052071122 ()
- 09120052071139 ()
30185384
- Laboratory instrument/analyser application software IVD
This media contains the following registered Medical Devices:
(DI) 09120052070996 MAGELLAN V7.X
(DI) 09120052071009 MAGELLAN TRACKER V7.X
Tecan Austria GmbH
30182624 00
In Commercial Distribution
- 09120052071023 ()
- 09120052071030 ()
- 09120052071047 ()
- 09120052071054 ()
- 09120052071061 ()
- 09120052071078 ()
- 09120052071085 ()
30182624
- Laboratory instrument/analyser application software IVD
Reader control and data reduction software for Tecan Microplate Reader.
Tecan Austria GmbH
MAGELLAN TRACKER V7.X
In Commercial Distribution
- 09120052071009 ()
30183890
- Laboratory instrument/analyser application software IVD
Reader control and data reduction software for Tecan Microplate Reader.
Tecan Austria GmbH
MAGELLAN V7.X
In Commercial Distribution
- 09120052070996 ()
30183889
- Laboratory instrument/analyser application software IVD
This media contains V 7.3 of the following registered Medical Devices:
(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),
(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
Tecan Austria GmbH
30141795 00
Not in Commercial Distribution
- 09120052070934 ()
- 09120052070941 ()
- 09120052070927 ()
- 09120052070972 ()
- 09120052070965 ()
30141795
- Laboratory instrument/analyser application software IVD
Reader control and data reduction software for Tecan Microplate Reader.
Tecan Austria GmbH
MAGELLAN PRO TRACKER V 7.X
In Commercial Distribution
- 09120052070910 ()
- Laboratory instrument/analyser application software IVD
Reader control and data reduction software for Tecan Microplate Reader.
Tecan Austria GmbH
MAGELLAN PRO V 7.X
In Commercial Distribution
- 09120052070880 ()
- Laboratory instrument/analyser application software IVD
U.S. IFU Manual and CDs, BioPlex 2200 HIV Ag-Ab IFU 665-3465A
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution
- 00847865001281 ()
- 1 Each
665-3465A
- Laboratory instrument/analyser application software IVD
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2258
Not in Commercial Distribution
- 04953170390616 ()
- Operating room audiovisual data/device management system application software