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This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard White Light Imaging (WLI) and Linked Color Imaging (LCI) endoscopy imaging. This software is not intended to replace clinical decision making.
FUJIFILM CORPORATION
EW10-EC02
In Commercial Distribution
- 04547410541199 ()
- Endoscopic video image interpretive software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
VA3
In Commercial Distribution
- 04068151027013 ()
- PET system application software
- SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589501
In Commercial Distribution
- 04068151009477 ()
- PET system application software
- SPECT system application software
No Description
ULTROMICS LIMITED
Core 2.0
In Commercial Distribution
- 05060634690027 ()
- Radiology DICOM image processing application software
- Cardiac mapping system application software
- Ultrasound imaging system application software
No Description
ULTROMICS LIMITED
Core
In Commercial Distribution
- 05060634690003 ()
- Radiology DICOM image processing application software
- Cardiac mapping system application software
- Ultrasound imaging system application software
cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC).
cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC.
The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection. The device results should not be used alone to make any diagnosis and/or treatment decisions.
Curemetrix, Inc.
V1.6
In Commercial Distribution
- 00860006442699 ()
- Radiology DICOM image processing application software
cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC).
cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC.
The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection and should not be used alone to make any diagnosis and/or treatment decisions.
cmAngio is for prescription use only.
Curemetrix, Inc.
V1.0
In Commercial Distribution
- 00860006442682 ()
- Radiology DICOM image processing application software
The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 3
In Commercial Distribution
- 00853341006053 ()
- Vascular modelling software
The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries.
The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease.
The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 2
In Commercial Distribution
- 00853341006039 ()
- Vascular modelling software
HeartFlow FFRct is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease. FFRct is independent of imaging equipment, imaging protocols and equipment vendors; the clinical validation report includes identification of vendors and equipment used in the clinical validation of the product. This data is summarized in the product labeling, and can be found in the Clinical User Instructions for Use. HeartFlow FFRct analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
v2.18
In Commercial Distribution
- 00853341006022 ()
- Vascular modelling software