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Server based HeRO System
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution
- 00865536000203 ()
- Neonatal/paediatric heart rate monitoring hardware
- Neonatal/paediatric heart rate monitoring application software
No Description
CLEAR GUIDE MEDICAL, INC.
CGSCENERGY
In Commercial Distribution
- B201CGSCENERGY1 ()
- B201CGSCENERGY0 ()
- Ultrasound imaging system application software
- Stereotactic system application software
72TB server for use with the Genius™ Digital Diagnostics System for short term digital storage.
Hologic, Inc.
INFORMATION MANAGEMENT SYSTEM, LARGE
In Commercial Distribution
- 15420045513976 ()
ASY-14451
- Microscope slide digital imaging scanner IVD
- Laboratory instrument/analyser application software IVD
32TB server for use with the Genius™ Digital Diagnostics System for short term digital storage.
Hologic, Inc.
INFORMATION MANAGEMENT SYSTEM, BASE
In Commercial Distribution
- 15420045513921 ()
ASY-14305
- Laboratory instrument/analyser application software IVD
- Microscope slide digital imaging scanner IVD
Norav 1200 Series PC-ECG Software Kit with the following Option(s):
- Upgrade from SOFT-NH300-1 to SOFT-NH301-4,Kit
The Kit includes:
Software Protection Key - "HASP-Key"
Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300 DL-Rv to 301
In Commercial Distribution
- 07290110252694 ()
HASP-SW-KNH300-1-UP-1
- Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s):
- I2 = Resting-ECG Measurement and Advanced Interpretation
The Kit includes:
Software Protection Key - "HASP-Key"
Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW I2
In Commercial Distribution
- 07290110252632 ()
HASP-SW-K-I2-01
- Patient-administration information system application software
- Cardiopulmonary stress exercise monitoring system computer
- Cardiovascular risk evaluation interpretive software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.2
In Commercial Distribution
- 04260521363534 ()
- Dental milling system, CAD/CAM, chairside
- CAD/CAM software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles
and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental
laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid
abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer
of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.0
In Commercial Distribution
- 04260521363510 ()
- CAD/CAM software
- Dental milling system, CAD/CAM, chairside
The Ceramill M-Plant module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. Ceramill M-Plant is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.1
In Commercial Distribution
- 04260521363619 ()
- Dental milling system, CAD/CAM, chairside
- CAD/CAM software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.1
In Commercial Distribution
- 04260521363527 ()
- Dental milling system, CAD/CAM, chairside
- CAD/CAM software
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
Eko Devices, Inc.
v7.x
In Commercial Distribution
- 00850010298146 ()
ELEFT
- Cardiopulmonary physiological parameter analysis software
Mobile application used by patients for disease management
Takeda Pharmaceuticals U.S.A., Inc.
V2
In Commercial Distribution
- 00850025688826 ()
- Home pharmaceutical management support software
No Description
Sugarmate, LLC
1008182
In Commercial Distribution
- 00850018992626 ()
- Self-care monitoring/reporting software
No Description
Sugarmate, LLC
1008181
In Commercial Distribution
- 00850018992619 ()
- Self-care monitoring/reporting software
No Description
Sugarmate, LLC
1008180
In Commercial Distribution
- 00850018992602 ()
- Self-care monitoring/reporting software
No Description
Sugarmate, LLC
1007228
In Commercial Distribution
- 00850018992435 ()
- Self-care monitoring/reporting software
No Description
Bigfoot Biomedical, Inc.
SW-300983
In Commercial Distribution
- 00850003506517 ()
SW-300983
- Self-care monitoring/reporting software
The Stratus EEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal.
The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Acquisition
- Bioelectrical signal analysis software
The Lifelines iEEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Acquisition systems consist of the Lifelines iEEG software, an EEG amplifier and an off the shelf computer, along with various additional options such as video cameras (1 or 2), a photic stimulator and a bag or a cart for the system.
Kvikna Medical ehf.
Acquisition
Not in Commercial Distribution
- 05694110063090 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW2050
Not in Commercial Distribution
- 05694110063083 ()
- Electroencephalograph
- Electroencephalographic monitoring system
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1050
Not in Commercial Distribution
- 05694110063076 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1040
Not in Commercial Distribution
- 05694110063045 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1030
Not in Commercial Distribution
- 05694110063038 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1010
Not in Commercial Distribution
- 05694110063021 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1022
Not in Commercial Distribution
- 05694110063014 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1020
Not in Commercial Distribution
- 05694110063007 ()
- Electroencephalograph
- Electroencephalographic monitoring system
Persyst ESI powered by Epilog provides Electrical Source Imaging as a service to a clinical user. The clinical user does not interact directly with the device. In the Persyst ESI powered by Epilog service, the device is used by Epilog operators to generate a report.
Persyst ESI powered by Epilog is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
v2
- Bioelectrical signal analysis software
PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image.
Clouds of Care
v2
- Bioelectrical signal analysis software
PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least
3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images
of an individualized head model and an individualized MRI image.
Clouds of Care
1.0.0
Not in Commercial Distribution
- 05430000733007 ()
- Bioelectrical signal analysis software
Web application used by Healthcare Professionals to generate dose calculations
Takeda Pharmaceuticals U.S.A., Inc.
V3
In Commercial Distribution
- 00850025688819 ()
- Home pharmaceutical management support software