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ENDOPRO IQ (PER MOBILE CART)
PENTAX OF AMERICA, INC.
M70209-UP
In Commercial Distribution
- 04961333243570 ()
- Radiology information system
ENDOPRO IQ (PER MOBILE CART)
PENTAX OF AMERICA, INC.
M70209
In Commercial Distribution
- 04961333243563 ()
- Radiology information system
ENDOPRO IQ AMBULATORY SITE LICENSE
PENTAX OF AMERICA, INC.
M70208-UP
In Commercial Distribution
- 04961333243556 ()
- Radiology information system
ENDOPRO IQ AMBULATORY SITE LICENSE
PENTAX OF AMERICA, INC.
M70208
In Commercial Distribution
- 04961333243549 ()
- Radiology information system
ENDOPRO IQ HOSPITAL SITE LICENSE
PENTAX OF AMERICA, INC.
M70207-UP
In Commercial Distribution
- 04961333243532 ()
- Radiology information system
ENDOPRO IQ HOSPITAL SITE LICENSE
PENTAX OF AMERICA, INC.
M70207
In Commercial Distribution
- 04961333243525 ()
- Radiology information system
ENDOPRO IQ CAPTURE LICENSE
PENTAX OF AMERICA, INC.
M70206-UP
In Commercial Distribution
- 04961333243518 ()
- Radiology information system
ENDOPRO IQ CAPTURE LICENSE
PENTAX OF AMERICA, INC.
M70206
In Commercial Distribution
- 04961333243501 ()
- Radiology information system
ENDOPRO IQ REVIEW LICENSE (5-9)
PENTAX OF AMERICA, INC.
M70205-UP
In Commercial Distribution
- 04961333243495 ()
- Radiology information system
ENDOPRO IQ REVIEW LICENSE (5-9)
PENTAX OF AMERICA, INC.
M70205
In Commercial Distribution
- 04961333243488 ()
- Radiology information system
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
ENDOPORTAL WORKSTATION LICENSE
PENTAX OF AMERICA, INC.
9252-1
In Commercial Distribution
- 04961333242702 ()
- Radiology information system
50 SDI TO SDI CABLE
PENTAX OF AMERICA, INC.
92215/50
In Commercial Distribution
- 04961333242689 ()
- Length: 50.0 Feet
- Radiology information system
12 SDI TO SDI CABLE
PENTAX OF AMERICA, INC.
92215/12
In Commercial Distribution
- 04961333242665 ()
- Length: 12.0 Feet
- Radiology information system
VGA TO S-VIDEO CABLE
PENTAX OF AMERICA, INC.
92213/25
In Commercial Distribution
- 04961333242634 ()
- Length: 25.0 Feet
- Radiology information system
DVI-D FIBER OPTIC CABLE 50FT (M-M)
PENTAX OF AMERICA, INC.
92212/50
In Commercial Distribution
- 04961333242610 ()
- Length: 50.0 Feet
- Radiology information system
CBL, ST - LC 62.5/125 4 CT BKT 12
PENTAX OF AMERICA, INC.
92189/12
In Commercial Distribution
- 04961333242535 ()
- Length: 12.0 Feet
- Radiology information system
CABLE FOR CV-140/160/180/190
PENTAX OF AMERICA, INC.
92185/6
In Commercial Distribution
- 04961333242481 ()
- Length: 6.0 Feet
- Radiology information system
CABLE: CV-100/200 DATA INTERF
PENTAX OF AMERICA, INC.
92184/6
In Commercial Distribution
- 04961333242474 ()
- Length: 6.0 Feet
- Radiology information system
CBL,NETWRK INTRF, 6 RJ45-D9F U/W EPK1000
PENTAX OF AMERICA, INC.
92171/6
In Commercial Distribution
- 04961333242399 ()
- Length: 6.0 Feet
- Radiology information system
CBL,NETWRK INTRF, 25 RJ45-D9F U/W EPK100
PENTAX OF AMERICA, INC.
92171/25
In Commercial Distribution
- 04961333242382 ()
- Length: 25.0 Feet
- Radiology information system
CBL,NETWRK INTRF, 12 RJ45-D9F U/W EPK100
PENTAX OF AMERICA, INC.
92171/12
In Commercial Distribution
- 04961333242375 ()
- Length: 12.0 Feet
- Radiology information system
EXTRON DATA CABLE
PENTAX OF AMERICA, INC.
92169/6
In Commercial Distribution
- 04961333242368 ()
- Length: 6.0 Feet
- Radiology information system
CBL,9DM-4BNC,6 EPK TO MON.
PENTAX OF AMERICA, INC.
92093/6
In Commercial Distribution
- 04961333242344 ()
- Length: 6.0 Feet
- Radiology information system
CBL,9DM-4BNC EPK TO MONITOR
PENTAX OF AMERICA, INC.
92093/25
In Commercial Distribution
- 04961333242337 ()
- Length: 25.0 Feet
- Radiology information system
CBL,VGA VIDEO EXT,25 15DM-15DF
PENTAX OF AMERICA, INC.
92090/25
In Commercial Distribution
- 04961333242290 ()
- Length: 25.0 Feet
- Radiology information system
CBL,RJ45-RJ45,10,TP
PENTAX OF AMERICA, INC.
92052/10
In Commercial Distribution
- 04961333242269 ()
- Length: 10.0 Feet
- Radiology information system
EXTRON 4 CHANNEL VGA VIDEO SWITCH
PENTAX OF AMERICA, INC.
68404
In Commercial Distribution
- 04961333240890 ()
- Radiology information system
FILE SERVER DELUXE RACK MOUNTABLE
PENTAX OF AMERICA, INC.
68394
In Commercial Distribution
- 04961333240876 ()
- Radiology information system
DATA INTERFACE: OLYMPUS/FUJINON
PENTAX OF AMERICA, INC.
68384
In Commercial Distribution
- 04961333240869 ()
- 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
Ultrasound imaging system application software
ECHONOUS, INC.
P006576
In Commercial Distribution
- 09353278000588 ()
- Ultrasound imaging system 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