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EchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic Echocardiogram, and assists the user in reviewing the images, making measurements and writing a report. This includes automatic view classification; segmentation of cardiac structures including the left and right ventricle, chamber walls, left and right atria and great vessels; measures of cardiac function; and Doppler assessments.
MYCARDIUM AI LIMITED
01.01.00(USA)
In Commercial Distribution
- 05061038730050 ()
EchoConfidence
- Cardiac mapping 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
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
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
TrackX adapter that enables physicians to more adequately track INSIGHT SNAPs that are placed on instruments that undergo heavier malleting forces.
TrackX Technology, LLC
TrackX Modular Malleting Adapter
In Commercial Distribution
- 00850073646038 ()
TX-3-4369
- Diagnostic x-ray digital imaging system workstation application software
X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-03
In Commercial Distribution
- 05415067053145 ()
ENSITE-D-FWV-03
- Cardiac mapping system application software
X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-03
In Commercial Distribution
- 05415067053138 ()
ENSITE-FWV-03
- Cardiac mapping system application software
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.1.1
In Commercial Distribution
- 05415067053121 ()
ENSITE-SW-3.1.1
- Cardiac mapping system application software
X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-02
In Commercial Distribution
- 05415067051110 ()
ENSITE-FWV-02
- Cardiac mapping system application software
X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled Software License
ST. JUDE MEDICAL, INC.
ENSITE-HDGX-01
In Commercial Distribution
- 05415067051103 ()
ENSITE-HDGX-01
- Cardiac mapping system application software