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inHEART MODELS Shaper is a standalone image processing software used to generate digital 3D models of the patient heart from medical images acquired by CT and/or MR devices.
inHEART MODELS Shaper is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists,
radiologists, and technicians) and the users are solely responsible for making all final patient management decisions.
INHEART
v1.4.0
Not in Commercial Distribution
- 03770019599037 ()
- Image segmentation application software
Ceevra Reveal 2.0 is a software-only device that allows clinicians to review CT and MR image data in three-dimensional (3D) format and/or stereoscopic 3D format (commonly known as virtual reality, or VR). The 3D and VR images are accessible through the Ceevra Reveal 2.0 mobile application which is used by clinicians for preoperative surgical planning and to support intraoperative decision making. Ceevra Reveal 2.0 includes two main software-based user interface components, the Processing Interface and Viewer Interface. The Processing Interface is hosted on a cloud-based, virtual workstation and only accessed by authorized personnel, such as an imaging technician. The Processing Interface contains a graphical user interface where an imaging technician can select DICOM-compatible medical images, segment such images, and initiate processing into a 3D format. The Viewer Interface is a mobile application that is accessible via a compatible, touchscreen enabled, off-the-shelf mobile device to allow for clinicians to review the medical images in 3D and/or VR formats. Only when the compatible mobile device is used in conjunction with a compatible off-the-shelf VR headset can the surgeon view medical images in the VR format. The product is intended to be used by trained medical professionals, including imaging technicians and clinicians/surgeons, and is used to assist in clinical decision making.
Ceevra, Inc.
2.10
In Commercial Distribution
- 00086162500046 ()
- Image segmentation application software
The Huma platform is a modular Software as a Medical Device (SaMD) which
may utilise compatible devices and software to obtain data collated via a
mobile app or web app and delivered to the clinician via a web portal or web
app where it may be viewed to drive clinical management. It is intended to be
used for the physiological and non-physiological intermittent or spot-check
monitoring of all condition patients in professional healthcare facilities, such
as clinics, hospitals or skilled nursing facilities, or in the patient’s home
setting. It is intended for the monitoring of patients by trained healthcare
professionals.
The Huma platform comprises a number of different modules and
functionalities that can be selected by the customer for configuration of care
plans which can be further personalised for the patients.
Clinical information collected from these modules is displayed on a clinician
web portal and patient app with the addition of flagging out of range
datasets, trend visualisation, goal setting and communication channels
between clinicians and patients.
MedoPad Inc.
1.34
In Commercial Distribution
- G2871002 ()
1002
- Self-care monitoring/reporting software
No Description
THINK SURGICAL, INC.
109939
In Commercial Distribution
- M9461099390 ()
109939
- Stereotactic system application software
No Description
THINK SURGICAL, INC.
109000
In Commercial Distribution
- M9461090000 ()
109000
- Stereotactic system application software
NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.7.0
In Commercial Distribution
- 00814901021558 ()
RS-0049
- Bioelectrical signal analysis software
NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.6.1
In Commercial Distribution
- 00814901021497 ()
RS-0049
- Bioelectrical signal analysis software
NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.6.0
Not in Commercial Distribution
- 00814901021466 ()
RS-0049
- Bioelectrical signal analysis software
NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.5.2
Not in Commercial Distribution
- 00814901021459 ()
RS-0049, RS-0152
- Bioelectrical signal analysis software
NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.5.0
Not in Commercial Distribution
- 00814901021428 ()
RS-0049
- Bioelectrical signal analysis software