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Exo Imaging, Inc.
EW1001
In Commercial Distribution
- 00850018318013 ()
- Ultrasound imaging system application software
twiist Replacement Pump Kit
SEQUEL MED TECH, LLC
DKPI-11098-001
In Commercial Distribution
- 00850017421479 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
twiist Disposable Cassette Pack (Sterile)
SEQUEL MED TECH, LLC
DKPI-11099-001
In Commercial Distribution
- 00850017421431 ()
- 00850017421448 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
twiist Disposable Cassette
SEQUEL MED TECH, LLC
DKPI-11073-001
In Commercial Distribution
- 00850017421431 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
twiist Pump Starter Kit
SEQUEL MED TECH, LLC
DKPI-11029-007
In Commercial Distribution
- 00850017421424 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
twiist Pump Assembly, Labeled
SEQUEL MED TECH, LLC
DKPI-21073-007
In Commercial Distribution
- 00850017421400 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Dose activity calculator for Selective Internal Radiation Therapy (SIRT)
SIRTEX MEDICAL PTY LTD
X-SMAC-01
In Commercial Distribution
- 00850014612108 ()
- Clinical management support 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
CytoVision V7.6 configuration
Leica Biosystems Richmond, Inc.
23SWR00076CV
Not in Commercial Distribution
- 00849832013419 ()
- Device Size Text, specify:
- Laboratory instrument/analyser application software IVD