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QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diagnosis (CADe/CADx) image processing software. QP-Prostate® CAD uses AI-based algorithms trained with pathology data to detect suspicious lesions for clinically significant prostate cancer. The device automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI and provides marks over regions of the images that may contain suspected lesions. There are two possible markers that are provided in the different colors suggesting different levels of suspicion of clinically significant prostate cancer (moderate or high suspicion level).
QUIBIM SOCIEDAD LIMITADA.
1.0
In Commercial Distribution
- 08437021468120 ()
- MRI image interpretive software
No Description
BIOCARE MEDICAL LLC
IPS0001US
In Commercial Distribution
- 00847627031716 ()
- Microscope slide maker/digital imaging analyser IVD
Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist.
PAIGE.AI, INC.
1.X
In Commercial Distribution
- 00860007599118 ()
- Histology/cytology/microbiology image-analysis interpretive software IVD
No Description
PathAI, Inc.
11124001
In Commercial Distribution
- 00860006696221 ()
- Histology/cytology/microbiology image-analysis interpretive software IVD
No Description
VENTANA MEDICAL SYSTEMS, INC.
v5
In Commercial Distribution
- 04015630985043 ()
06324444001
- Histology/cytology/microbiology image-analysis interpretive software IVD
No Description
LINKVERSE SRL
4.0.1-S
In Commercial Distribution
- 78055060110375 ()
- 08055060110376 ()
CPRO401S-US
- Endoscopic video image interpretive software
Software to be used in GI Genius™ systems.
LINKVERSE SRL
4.0.1
In Commercial Distribution
- 78055060110344 ()
- 08055060110345 ()
CPRO401-US
- Endoscopic video image interpretive software
No Description
LINKVERSE SRL
CPRO40.US
In Commercial Distribution
- 78055060110290 ()
- 08055060110291 ()
- Endoscopic video image interpretive software
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
Chengdu Wision Medical Device Co., Ltd.
WIPD01
In Commercial Distribution
- 06973770840012 ()
- Endoscopic video image interpretive software