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The Rail Extender intended use is to make the Smith & Nephew T-Max Beach Chair compatible with the Enovis Adaptable Arm, by extending the Rail of the Back Side of the T-Max to install the Adaptable Arm, achieving a complete exposure and mobility on the patient arm.
Quantum Ops, Inc.
Adaptable Rail Extender
In Commercial Distribution
- 00860012987818 ()
804-33-006
- Arm procedure positioner, reusable
No Description
Quantum Ops, Inc.
Arvis C Tracker Mount
In Commercial Distribution
- 00860012987801 ()
804-33-005
- Arm procedure positioner, reusable
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
PathAI, Inc.
11124001
In Commercial Distribution
- 00860006696221 ()
- Histology/cytology/microbiology image-analysis interpretive software 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
VENTANA MEDICAL SYSTEMS, INC.
v5
In Commercial Distribution
- 04015630985043 ()
06324444001
- Histology/cytology/microbiology image-analysis interpretive software IVD
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
No Description
LINKVERSE SRL
4.0.1-S
In Commercial Distribution
- 78055060110375 ()
- 08055060110376 ()
CPRO401S-US
- Endoscopic video image interpretive software
Ibex Prostate Detect is a software only device intended to analyze scanned histopathology whole slide images (WSIs) from prostate core needle biopsies (PCNB) prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. The device is intended to identify cases initially diagnosed as benign for further review by a pathologist. If Ibex Prostate Detect detects tissue morphology suspicious for prostate adenocarcinoma (AdC), it provides case- and slide-level alerts (flags) which includes a heatmap of tissue areas in the WSI that is likely to contain cancer.
Ibex Prostate Detect is intended to be used with slide images digitized with Philips Ultra Fast Scanner and visualized using the Ibex Prostate Detect user interface.
Ibex Prostate Detect outputs are not intended to be used on a standalone basis for diagnosis, to rule out prostatic AdC or to preclude pathological assessment of WSIs according to the standard of care.
IBEX MEDICAL ANALYTICS LTD
3.1-US
In Commercial Distribution
- 07290019124016 ()
- Histology/cytology/microbiology image-analysis interpretive software IVD