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Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.4.0
In Commercial Distribution
- 00628011382146 ()
- Radiation therapy software
The SpassageQ is a SaMD that automatically calculates the patient’s qSOFA score based on the six vital signs received from the HL7 gateway system and the GCS directly entered by the healthcare provider and notifies the user of signs of sepsis through visual alarms.
Spass Co.,Ltd.
1.0.0
In Commercial Distribution
- 08809957910002 ()
- Physiologic monitor-installed software
No Description
BIOFOURMIS SINGAPORE PTE. LTD.
2.0
In Commercial Distribution
- 08885018690021 ()
- Physiologic monitor-installed software
No Description
TOPCON CORPORATION
IMAGEnet 6
In Commercial Distribution
- 04562123288582 ()
- Ophthalmology PACS software
ULTRASOUND DATA ANALYSIS SYSTEM
HITACHI, LTD.
DAS-RS1
Not in Commercial Distribution
- 04562122958639 ()
- Radiological PACS software
No Description
TOPCON CORPORATION
IMAGEnet 5
In Commercial Distribution
- 04562123288308 ()
- Camera application software
No Description
MedicalCommunications GmbH
2.6.5 (Build 2167)
In Commercial Distribution
- 04260648620060 ()
- Ophthalmology PACS software
No Description
MedicalCommunications GmbH
2.5
In Commercial Distribution
- 04260648620015 ()
- Ophthalmology PACS software
Version 5.4+ includes all minor versions and patch levels of 5.4 as well as higher versions (e.g. 5.5) in case no new 510(k) submission is needed.
VISUS Health IT GmbH
5.4+
In Commercial Distribution
- 04260632470084 ()
- Radiological PACS software
Version 5.3 includes all minor versions and patch levels of 5.3
VISUS Health IT GmbH
5.3
Not in Commercial Distribution
- 04260632470039 ()
- Radiological PACS software