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Dental instruments designed for the placement and construction of a dental prostheses.
RHEIN 83 SRL
INSTRUMENT SET (CAI)
Not in Commercial Distribution
- D8210003 ()
- Dental implant suprastructure, permanent, preformed
2-channel (4 electrodes)
Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)
MT MonitorTechnik GmbH & Co. KG
PKM4
In Commercial Distribution
- 04260497025016 ()
- Electroencephalographic monitoring system
1-channel (3 electrodes)
Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)
MT MonitorTechnik GmbH & Co. KG
PKM1
In Commercial Distribution
- 04260497025009 ()
- Electroencephalographic monitoring system
No Description
MT MonitorTechnik GmbH & Co. KG
T5
In Commercial Distribution
- 04260497021063 ()
- 04260497021070 ()
- Electroencephalographic monitoring system
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094940763 ()
- Self-care monitoring/reporting software
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094940756 ()
- Self-care monitoring/reporting software
cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the high-gamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.
g.tec medical engineering GmbH
TD 1.x
In Commercial Distribution
- EBCI80600 ()
- Electroencephalographic spectrum analyser
Rapid System Update
Ischemaview, Inc.
5.101
In Commercial Distribution
- B761R51011 ()
- Radiological PACS 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 soft‐
ware 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
4.0.6
Not in Commercial Distribution
- 00864747000279 ()
- 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 soft‐
ware 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
4.0.4
Not in Commercial Distribution
- 00864747000262 ()
- 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 soft‐
ware 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
4.0.3
Not in Commercial Distribution
- 00864747000255 ()
- 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 soft‐
ware 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
4.0.2
Not in Commercial Distribution
- 00864747000248 ()
- 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 soft‐
ware 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
4.0.1
Not in Commercial Distribution
- 00864747000224 ()
- 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 soft‐
ware 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
4.0.0
Not in Commercial Distribution
- 00864747000217 ()
- 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 soft‐
ware 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
3.0.1
Not in Commercial Distribution
- 00864747000200 ()
- MRI system application software
IQ HOLTER PLUG-IN SOFTWARE v10.0.6: New Software Release for Midmark Digital Holter.
MIDMARK CORPORATION
P/N 4-100-3140
In Commercial Distribution
- 00841709118067 ()
- Electrocardiographic long-term ambulatory recording analyser
Software, CyberKnife Version 11.1 (Software group that operates CyberKnife Treatment Delivery System)
ACCURAY INCORPORATED
1061945
In Commercial Distribution
- 00811376030023 ()
NA
- Linear accelerator system
Software, Version 11.0, CyberKnife
(Operating Software group for CyberKnife Treatment Delivery System)
ACCURAY INCORPORATED
1055810
In Commercial Distribution
- M6581055810 ()
NA
- Linear accelerator system
Norav 1200 Series PC-ECG Software Kit with the following Option(s):
- S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer)
- S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools
- 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 S2-I2
In Commercial Distribution
- 07290110255022 ()
HASP-SW-K-S2I2-01
- Patient-administration information system application software
- Cardiovascular risk evaluation interpretive software
- Cardiopulmonary stress exercise monitoring system computer
Norav 1200 Series PC-ECG Software Kit for COSMED with the following Option(s):
- S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer)
- S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools
- I1 = Restin-ECG Measurement
The Kit includes:
Software Protection Key - "HASP-Key"
Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I1
In Commercial Distribution
- 07290110252793 ()
HASP-SW-K-S2I1-01
- Cardiovascular risk evaluation interpretive software
- Cardiopulmonary stress exercise monitoring system computer