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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
No Description
Imeka Solutions Inc
1
In Commercial Distribution
- 00754016387111 ()
- Radiological PACS software
No Description
Change Healthcare Canada Company
1.0.19
Not in Commercial Distribution
- 17540262130201 ()
- Radiological PACS software
No Description
Change Healthcare Canada Company
1.0.18
Not in Commercial Distribution
- 17540262130195 ()
- 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
No Description
Synaptive Medical Inc
13.1
Not in Commercial Distribution
- 00670082000139 ()
SYN-0524
- Radiological PACS software
No Description
Synaptive Medical Inc
1.1
Not in Commercial Distribution
- 00670082000122 ()
SYN-0627
- Radiological PACS software
No Description
Synaptive Medical Inc
1.1
In Commercial Distribution
- 00670082000115 ()
SYN-0578
- Radiological PACS software
No Description
Synaptive Medical Inc
1.3
Not in Commercial Distribution
- 00670082000085 ()
SYN-0004
- Radiological PACS software
ExamVue PACS version 1.1 Build 81
TELEVERE SYSTEMS, LLC
1.1 Build 81
In Commercial Distribution
- 00851800007078 ()
ExamVue PACS 1.1 Build 81
- Radiological PACS software
- General-purpose dental x-ray system application software
- Multidisciplinary medical image management software
- Camera application software
- Basic diagnostic x-ray system application software
Norav 1200 Series PC-ECG Software Kit with the following Option(s):
- HL7 Integration Engine
The Kit includes:
Software Protection Key - "HASP-Key"
Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NHL7
In Commercial Distribution
- 07290110252595 ()
HASP-SW-K-NHL7IE-01
- Medical equipment clinical data interfacing software
The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associated sensor analysis including real-time data analysis as the data is collected. The Analysis software also contains all of the features of the Management Software: The DataLINK Management Software allows the user to set up the DataLINK communications with the computer, configure the sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data
Software is available in English, Chinese, and Japanese.
BIOMETRICS LIMITED
310xx-11
In Commercial Distribution
- 05060481691949 ()
- Bio-energy mapping system application software
The DataLINK Management Software allows the user to set up the DataLINK communications with the computer, configure the sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data to third party software.
Software is available in English, Chinese, and Japanese.
BIOMETRICS LIMITED
310xx-00
In Commercial Distribution
- 05060481691932 ()
- Bio-energy mapping system application software
The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associated sensor analysis including real-time data analysis as the data is collected. The Analysis software also contains all of the features of the Management Software: The DataLITE Management Software allows the user to set up the DataLITE communications with the computer, configure the DataLITE sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data
Software is available in English, Chinese, and Japanese.
BIOMETRICS LIMITED
510xx-11
In Commercial Distribution
- 05060481690867 ()
- Bio-energy mapping system application software
The DataLITE Management Software allows the user to set up the DataLITE communications with the computer, configure the DataLITE sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data to third party software.
Software is available in English, Chinese, and Japanese.
BIOMETRICS LIMITED
510xx-100
In Commercial Distribution
- 05060481690850 ()
- Bio-energy mapping system application software
The swiftPro Cradle is the stand for the swiftPro Hand-Held Microwave Generator when not in use.
EMBLATION LIMITED
SWF-CRA01
In Commercial Distribution
- 05060652910084 ()
SWF-CRA01
- Microwave hyperthermia system
The swiftPro Hand-Held microwave generator is intended to be used with the swiftPro applicator tip for the coagulation of soft tissue.
EMBLATION LIMITED
SWF-HAN01
In Commercial Distribution
- 05060652910060 ()
SWF-HAN01
- Microwave hyperthermia system
swiftPro System
EMBLATION LIMITED
SWF-MIC01
In Commercial Distribution
- 05060652910053 ()
SWF-MIC01
- Microwave hyperthermia system
The Swift® microwave generator is intended to be used with the Swift® applicator for the coagulation of soft tissue.
EMBLATION LIMITED
SWF-GE01
In Commercial Distribution
- 05060652910008 ()
SWF-GE01
- Microwave hyperthermia system
Remidio FOP application along with FOP NM-10 hardware is intended for use in capturing & storing images of the retina and surrounding area of eye, with or without the use of Mydriatic agent and presenting the data to clinicians for evaluation or diagnosis. Light from the device is shown into the patient eye & the camera of a smartphone is used to capture images of the eye.
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
Remidio FOP
In Commercial Distribution
- 08906096520052 ()
- Ophthalmic image analysis software
The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.
Pyrexar Medical Inc.
BSD-2000U
- Microwave hyperthermia system
The BSD-500 Hyperthermia System delivers therapeutic heat to certain surface or subsurface malignant tumors by the external or interstitial application of electromagnetic energy and monitors the temperature of target and surrounding tissues by means of independent temperature sensors.
Pyrexar Medical Inc.
BSD-500
- Microwave hyperthermia system
The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.
Pyrexar Medical Inc.
BSD-2000B
- Microwave hyperthermia system