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OR Integration software module Version 6 that allows the remote control of surgical lights during a surgical procedure.
BLACK DIAMOND VIDEO, INC.
IDSS-SLC
Not in Commercial Distribution
- 00724995152031 ()
- Operating room audiovisual data/device management system application software
No Description
VINEHEALTH DIGITAL LIMITED
R1 V3
In Commercial Distribution
- 05070000764122 ()
- Clinical management support software
ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD)
which assists qualified healthcare professionals to identify anatomy in live ultrasound images.
The Anatomy PNB receives scan images in real-time from a compatible general-purpose
ultrasound machine. It then processes the images using deep learning artificial intelligence
algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The
original view from the ultrasound machine is not affected and is always available both on the
ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V2.0
Not in Commercial Distribution
- 05060878810052 ()
- Ultrasound imaging system application software
ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD)
which assists qualified healthcare professionals to identify anatomy in live ultrasound images.
The Anatomy PNB receives scan images in real-time from a compatible general-purpose
ultrasound machine. It then processes the images using deep learning artificial intelligence
algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The
original view from the ultrasound machine is not affected and is always available both on the
ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V1.1
Not in Commercial Distribution
- 05060878810021 ()
- Ultrasound imaging system application software
Software to identify heart failure patients who may be at risk of having wtATTR-CM
PFIZER INC.
CI4054279
In Commercial Distribution
- 05415062388310 ()
- Cardiovascular interpretive screening software
Clinical decision support software indicated for use by licensed clinicians to inform the detection of disease utilizing an iOS client.
AMBIENT CLINICAL ANALYTICS, INC.
1.0
In Commercial Distribution
- 00850893007033 ()
- Clinical management support software
Clinical decision support software for disease detection and response indicated for use by licensed clinicians in a clinical setting.
AMBIENT CLINICAL ANALYTICS, INC.
1.1
In Commercial Distribution
- 00850893007026 ()
- Clinical management support software
Clinical decision support software indicated for use by licensed clinicians in a clinical setting integrated with Philips ICCA product.
AMBIENT CLINICAL ANALYTICS, INC.
P1.0
In Commercial Distribution
- 00850893007019 ()
- Clinical management support software
No Description
AMBIENT CLINICAL ANALYTICS, INC.
1.1
In Commercial Distribution
- 00850893007002 ()
- Clinical management support software
AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer applicationwhere the DICOM viewer serves as the user interface and the interface to a PACS or scanner forAI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user andautomatically processes and analyses cardiac MR images received by the DICOM viewer toquantify relevant cardiac function metrics and makes the information available to the user at theuser’s discretion
Indications for use:
AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.
v1.0
In Commercial Distribution
- 05600250059022 ()
- MRI system application software
Personal Genome Service - Carrier Status Reports
23ANDME, INC.
YouDot (Carrier)
Not in Commercial Distribution
- 00862150000060 ()
- Human genomic analysis interpretive 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
NeoSoft’s CAKE product is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic breast MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.
The results may be displayed as either a grayscale enhancement or a color overlay on the selected image. CAKE may perform additional functions to aid in the analysis and viewing of dynamic studies including registration of serial MR acquisitions, labeling of tissue types based upon user specified enhancement characteristics, visualization and quantification of lesion morphology in 3D, segmentation of tissues, multi-planar reformats, maximum intensity projections, image averaging, and subtractions.
When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of CAKE analysis.
NEOSOFT LLC
3.0.0
In Commercial Distribution
- 00864747000231 ()
- 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
No Description
CORTECHS LABS INC
LQ
In Commercial Distribution
- 00863725000317 ()
- MRI system application software