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The Hybrid Navigation Unit EM is a high performance computer workstation with built-in electromagnetic Localization System. The workstation runs the navigation software NOVA which imports radiologic image via DICOM.
Scopis GmbH
2.2
In Commercial Distribution
- B057U2040040 ()
U2 040 04
- Electromagnetic/optical surgical navigation device tracking system
The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques.
Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution
- 00860002545707 ()
- Ultrasound imaging system application software
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 = Resting-ECG Measurement
- D1 = Norav ECG Management System NEMS
The Kit includes:
Software Protection Key - "HASP-Key"
Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I1-D1
In Commercial Distribution
- 07290110252809 ()
HASP-SW-K-S2I1D1-01
- Cardiopulmonary stress exercise monitoring system computer
- Cardiovascular risk evaluation interpretive software
- Patient-administration information system application software
Final software release for UDI-DI: T-2022.03.
Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as pre-operative software for diagnostic and surgical planning.
For these purposes, output files can also be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications.
The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.
SYNOPSYS, INC.
S-2021.06 onwards
Not in Commercial Distribution
- 00863520000390 ()
- Radiological PACS software
MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart.
A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out of complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by a physician and can be communicated to referring physicians to support the determination of a diagnosis.
MYOCARDIAL SOLUTIONS, INC.
5.4
In Commercial Distribution
- B673MYOSTRAIN05040 ()
- Radiology DICOM image processing application software
MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart.
A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out of complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by a physician and can be communicated to referring physicians to support the determination of a diagnosis.
MYOCARDIAL SOLUTIONS, INC.
5.2.3
In Commercial Distribution
- B673MYOSTRAIN0502030 ()
- Radiology DICOM image processing application software
MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart.
A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out of complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by a physician and can be communicated to referring physicians to support the determination of a diagnosis.
MYOCARDIAL SOLUTIONS, INC.
6.0.1
In Commercial Distribution
- B672MYOSTRAIN0600010 ()
- Radiology DICOM image processing application software
Norav 1200 Series PC-ECG Software Upgrade 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
The Kit includes:
Software Protection Key - "HASP-Key"
Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2toS2
In Commercial Distribution
- 07290110252786 ()
HASP-SW-K-S2-S1-01
- Cardiopulmonary stress exercise monitoring system computer
AmCAD UO is a PC based, self contained, non invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA cleared ultrasound system. The software is designed to support visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician’s evaluation and monitoring of the airway state.
AMCAD BIOMED CORPORATION
1.0
In Commercial Distribution
- 04719875623103 ()
UO-0102
- Ultrasound imaging system application software
LungPoint VBN Software is software installed on a desktop computer used to plan procedures and navigate to targets in the lung. The LungPoint Procedure Program offers real-time navigation guidance for use during the bronchoscopy procedure. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery.
BRONCUS MEDICAL INC.
30005
In Commercial Distribution
- 00856571007173 ()
30005
- Virtual bronchoscopic navigation PACS software