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CT Perfusion V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software allowing computation of parametric maps from CT Perfusion data and extraction of volumes of interest based on numerical thresholds applied to the aforementioned maps. Computation of mismatch between extracted volumes is automatically provided.
The device is intended to be used by trained professionals with medical imaging education including but not limited to, physicians and medical technicians in the imaging assessment workflow by extraction and communication of metrics from CT Perfusion dataset.
The results of CT Perfusion V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment. Trained professionals are responsible for viewing the full set of native images per the standard of care.
CT Perfusion V1.0 can be integrated and deployed through technical platforms.
Olea Medical USA
V1.0
In Commercial Distribution
- EOLECTPERFUSIONV1P00 ()
- Radiological PACS software
breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software package cleared under K152602. It is intended to be used by trained breast imaging physicians and trained MRI technologists.
breastscape V1.0 includes 2 software modules :
- BreastApp supports the visualization, analysis, and reporting of lesions measurements and analysis.
- BreastLoc to assist users in planning MR guided breast interventional procedures.
Data and images are acquired through DICOM compliant imaging devices and modalities.
Olea Medical USA
V1.0
In Commercial Distribution
- EOLEBREASTSCAPEV1P00 ()
- Radiological PACS software
Automation Platform V1.5 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Automation Platform V1.5 stores, converts formats and displays medical device data.
Automation Platform V1.5 allows the integration of separately registered or cleared processing applications owned by Olea Medical or third parties. These applications are not part of the platform itself.
Automation Platform V1.5 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Automation Platform V1.5 reads DICOM tags and pixel data to label images.
Automation Platform V1.5 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs.
Automation Platform V1.5 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan.
Automation Platform V1.5 is intended to be used by trained professionals. Automation Platform V1.5 is not intended for primary diagnosis, detailed treatment planning or treatment of patients and shall not be used to take decisions with diagnosis or therapeutic purposes.
Olea Medical USA
1.5
In Commercial Distribution
- EOLEAUTOMATIONV1P50 ()
- Radiological PACS software
The Automation Platform is a software product that transfers, stores, converts formats, and displays medical device image data. It does not modify the image data or modify the display of the image data.
The Automation Platform reads images and interprets DICOM tags, analyzes pixels to identify body part and sequence type in order to categorize the images.
The Automation Platform is not intended to be used for active patient monitoring nor primary image interpretation.
The Automation Platform allows routing DICOM-compliant image data to and from automated post processing applications, but such processing applications are not a part of the platform itself.
Automation Platform allows post processing applications to provide a notification or a flag intended to inform the user.
Olea Medical USA
1.0
Not in Commercial Distribution
- EOLEAUTOMATIONV1P01 ()
- Radiological PACS software
No Description
Synaptive Medical Inc
2.2
In Commercial Distribution
- 00670082000610 ()
SYN-0866
- Radiological PACS software
No Description
Synaptive Medical Inc
2.1
In Commercial Distribution
- 00670082000511 ()
SYN-0866
- Radiological PACS software
No Description
Synaptive Medical Inc
2.0
In Commercial Distribution
- 00670082000443 ()
SYN-0866
- Radiological PACS software
No Description
Synaptive Medical Inc
1.6
Not in Commercial Distribution
- 00670082000412 ()
SYN-0866
- Radiological PACS software
No Description
Synaptive Medical Inc
1.5
Not in Commercial Distribution
- 00670082000368 ()
SYN-0004
- Radiological PACS software
No Description
Synaptive Medical Inc
1.4
Not in Commercial Distribution
- 00670082000160 ()
SYN-0004
- Radiological PACS software