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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
SYSMEX CORPORATION
1.X
In Commercial Distribution

  • 04987562488506 ()
AB364503

  • Clinical laboratory information system
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
AIRFLOW PLUS
E.M.S. Electro Medical Systems S.A.
DV-165/X
In Commercial Distribution

  • 07613353208264 ()


  • Dental abrasive powder
No Description
M2S, INC.
4.x
Not in Commercial Distribution

  • B119PREVIEW0 ()


  • Radiology information system application software
No Description
H & O Equipments SA
CryoProbe|x
In Commercial Distribution

  • B386SHOCXPRXX8010 ()
S-HO-CXPR-XX-801

  • General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
CryoProbe|x+
In Commercial Distribution

  • B386SHOCXPRP000 ()
S-HO-CXPRP-00

  • General cryosurgical system, cryogen gas, mechanical
CapSure Cloud is a secure cloud-based web application for medical image archiving and management.
Globalmed Holdings, LLC
2.1.x
Not in Commercial Distribution

  • B377GMR1602008X0 ()


  • Multidisciplinary medical image management software
Lilly Health Personalized Health & Medicine Platform is intended for providing medication reminders, medication dose logging, and health data logging, depending upon the medicinal product prescribed or condition.
WELLDOC, INC.
1.X
In Commercial Distribution

  • B553202202OTC0 ()


  • Medication reminder application software
Lilly Health Personalized Health & Medicine Platform is intended for providing medication reminders, medication dose logging, and health data logging, depending upon the medicinal product prescribed or condition.
WELLDOC, INC.
1.X
In Commercial Distribution

  • B553202201OTC0 ()


  • Medication reminder application software
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