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Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.4.0
In Commercial Distribution
- 00628011382146 ()
- Radiation therapy software
-
NANO-X AI LTD
2.1
In Commercial Distribution
- 07290018016176 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
2.0
In Commercial Distribution
- 07290018016169 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.0
In Commercial Distribution
- 07290018016152 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.1
In Commercial Distribution
- 07290018016145 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.1
In Commercial Distribution
- 07290018016138 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.1
In Commercial Distribution
- 07290018016114 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.0
In Commercial Distribution
- 07290018016107 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.0
Not in Commercial Distribution
- 07290018016091 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.0
Not in Commercial Distribution
- 07290018016084 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
2.0.0
In Commercial Distribution
- 07290018016077 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
2.2
In Commercial Distribution
- 07290018016060 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
3.0.0
In Commercial Distribution
- 07290018016053 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.0.0
Not in Commercial Distribution
- 07290018016046 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
2.1.3
Not in Commercial Distribution
- 07290018016039 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
2.0.5
In Commercial Distribution
- 07290018016022 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.0.6
Not in Commercial Distribution
- 07290018016015 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
3.0.0
Not in Commercial Distribution
- 07290018016008 ()
- Radiology DICOM image processing application software
Tempus ECG-Low EF is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients 40 years of age or older at risk of heart failure. This population includes but is not limited to patients with atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation, and ischemic heart disease. Tempus ECG-Low EF only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-Low EF is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for patient monitoring, and should not be used on ECGs with paced rhythms. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history. A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of low LVEF. Patients receiving a negative result should continue to be evaluated in accordance with current medical practice standards using all available clinical information.
Tempus AI, Inc.
2
In Commercial Distribution
- 00860011843610 ()
- Cardiopulmonary physiological parameter analysis software
Quantum Workstation
SPECTRUM MEDICAL LIMITED
QWS
In Commercial Distribution
- 05060434420008 ()
51-000001-00
- Extracorporeal blood gas/pH monitor
The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps.
The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time
Iterative Scopes, Inc.
SKOUT210
In Commercial Distribution
- 00860010168417 ()
- Endoscopic video image interpretive unit
The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps.
The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time.
Iterative Scopes, Inc.
SKOUT200
In Commercial Distribution
- 00860010168400 ()
- Endoscopic video image interpretive unit
GI Genius™ system with software ColonPRO™.
LINKVERSE SRL
GGM300-US
In Commercial Distribution
- 08055060110338 ()
- Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM200.US
In Commercial Distribution
- 08055060110321 ()
- Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM100.US
In Commercial Distribution
- 08055060110314 ()
- Endoscopic video image interpretive unit
GGI Genius (TM) System 200
Covidien LP
GGS200
In Commercial Distribution
- 10884521844544 ()
- Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;
- Endoscopic video image interpretive unit
GGI Genius (TM) System 100
Covidien LP
GGS100
In Commercial Distribution
- 10884521844537 ()
- Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;
- Endoscopic video image interpretive unit
Intelligent Endoscopy Module , Refurbished
Covidien LP
CB1708-RFB
In Commercial Distribution
- 10884521821545 ()
- Endoscopic video image interpretive unit
Intelligent Endoscopy Module
Covidien LP
CB1708-EU
In Commercial Distribution
- 10884521807259 ()
- Voltage, 100- 240, VAC;+/-10%,50/60,Hertz;Power,240,W;
- Endoscopic video image interpretive unit
AI Acutrak® Comp Screw Handle Assy
Acumed LLC
80-0097
In Commercial Distribution
- 10806378039850 ()
- Surgical instrument handle, non-torque-limiting