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Blackford Dashboard v1.2, monitoring tool for users of the Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.2.x
In Commercial Distribution
- 05060570830082 ()
- Radiological PACS software
Blackford Smart Localizer v1.3.x, supplied with Blackford Platform (part of the Blackford Product Family)- previously marketed as the Blackford Registration Application
BLACKFORD ANALYSIS LIMITED
1.3.x
In Commercial Distribution
- 05060570830075 ()
- Radiological PACS software
Blackford Platform v2.2.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.2.x
In Commercial Distribution
- 05060570830068 ()
- Radiological PACS software
Blackford Registration Application v1.3.x, supplied with Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.3.x
In Commercial Distribution
- 05060570830044 ()
- Radiological PACS software
Blackford Platform v2.1.x, supplied with Blackford Registration Application (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.1.x
In Commercial Distribution
- 05060570830037 ()
- Radiological PACS software
Blackford Registration Application v1.2.x, supplied with Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.2.x
In Commercial Distribution
- 05060570830013 ()
- Radiological PACS software
Blackford Platform v2.0.x, supplied with Blackford Registration Application (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.0.x
In Commercial Distribution
- 05060570830006 ()
- Radiological PACS software
Non-powdered patient examination gloves
C&A Marketing, Inc.
X Large
In Commercial Distribution
- 00843812168458 ()
- 10843812168455 ()
WVEBNGXL
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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 leaming 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.
1.8.X
In Commercial Distribution
- 00628011382184 ()
- Radiation therapy software
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.
1.7.X
In Commercial Distribution
- 00628011382177 ()
- Radiation therapy software
No Description
BONRAYBIO CO., LTD.
X QC
In Commercial Distribution
- 04719874740733 ()
- Sperm concentration indicator IVD, control
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
Eko Devices, Inc.
v7.x
In Commercial Distribution
- 00850010298146 ()
ELEFT
- Cardiopulmonary physiological parameter analysis software
The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques.
Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution
- 00860002545707 ()
- Ultrasound imaging system application software
Protect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor
Reina Imaging
WDDR[X]
In Commercial Distribution
- 00860001700176 ()
- Footstool
- Flat panel x-ray detector/film cassette weight-bearing protector
Nitrile Examination Gloves
TEC GLOVES USA, LLC
X Large
In Commercial Distribution
- 00860009233577 ()
- 00860009233539 ()
TC21NXL
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Garmin International, Inc.
1.x
In Commercial Distribution
- 00860009117716 ()
- Cardiopulmonary physiological parameter analysis software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution
- 00860009117709 ()
- Cardiopulmonary physiological parameter analysis software
No Description
Whoop, Inc.
1.x
In Commercial Distribution
- 00860012964819 ()
- Electrocardiograph, home-use
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.3.x
- Vulnerable patient home-monitoring software, professional-only
SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
RADIALOGICA LLC
1.x
In Commercial Distribution
- 00863284000315 ()
- Radiation therapy software