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No Description
SIM&CURE
V1.1
In Commercial Distribution
- 03665786000063 ()
- Radiology DICOM image processing application software
No Description
SIM&CURE
V1.0.7
In Commercial Distribution
- 03665786000056 ()
- Radiology DICOM image processing application software
No Description
SIM&CURE
V1.0.6
In Commercial Distribution
- 03665786000049 ()
- Radiology DICOM image processing application software
No Description
SIM&CURE
V1.2
In Commercial Distribution
- 03665786000032 ()
- Radiology DICOM image processing application software
No Description
SIM&CURE
Version 1.0.5
In Commercial Distribution
- 03665786000025 ()
- Radiology DICOM image processing application software
No Description
Arterys Inc.
AMM7
- Radiology DICOM image processing application software
No Description
Arterys Inc.
AMM7
Not in Commercial Distribution
- B664AMM70 ()
- Radiology DICOM image processing application software
No Description
Arterys Inc.
AMM6
Not in Commercial Distribution
- B664AMM60 ()
- Radiology DICOM image processing application software
The VMS+ 4.0 system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing.
The VMS+ 4.0 system is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired.
VentriPoint Diagnostics Ltd
4.0
In Commercial Distribution
- 07540263000049 ()
- Radiology picture archiving and communication system workstation
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