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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
The Cydar EV software produces automated 3D overlays for use in endovascular surgery. The software detects vertebral anatomical information present in live X-ray images and matches ('registers') it to an existing CT scan of the patient in order to determine their precise position. This match then allows a 3D overlay to be generated in the correct position and projection. The Cydar EV software is hosted on cloud high-performance computers in order to accelerate performance
Cydar EV works with both flat panel detectors and image intensifiers on fixed and mobile X-ray sets. The Cydar EV Instructions for Use remain the same for all types of X-ray set.
Note: Federal law (US) restricts this device to sale by or on the order of a physician.
CYDAR LIMITED
EV-2
In Commercial Distribution
- 05060508110002 ()
- Angiographic x-ray 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
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 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
X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-02
In Commercial Distribution
- 05415067051097 ()
ENSITE-D-FWV-02
- Cardiac mapping system application software
X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-01
In Commercial Distribution
- 05415067050298 ()
ENSITE-FWV-01
- Cardiac mapping system application software
X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-01
In Commercial Distribution
- 05415067050281 ()
ENSITE-D-FWV-01
- Cardiac mapping system application software